The Regulatory Academy Blog

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The questions every cohort asks — about the career, the craft, and the first job — answered properly, in writing, by someone who does the work.

Latest Careers Writing to evidence already transfers. Owning the decision instead of documenting someone else’s is the whole distance left to close. Connor Griggs · 3 min read

The Blog

Asked in Office Hours.
Answered in Writing.

Short, practical essays on careers and craft in regulatory affairs — the questions every cohort asks, answered properly once.

163 essays

  1. Oct 212026
    Careers

    Moving From Medical Writing Into Regulatory Affairs

    Medical writers already know how to read the data regulators ask for — here is what changes, and what transfers, when you move into regulatory affairs itself.

    Connor Griggs · 3 min read
    A woman in a wheelchair, wearing a blazer, writes notes in a spiral notebook at a desk beside an open laptop
  2. Oct 212026
    Craft

    What an FDA Drug Shortage Notice Actually Requires

    Section 506C gives FDA a six-month warning before certain drugs disappear — here is what triggers the notice, who has to send it, and what FDA does with it.

    Connor Griggs · 3 min read
    A man in a white sweater reads a printed report at a minimalist white desk, a laptop open in front of him
  3. Oct 212026
    Craft

    What a Humanitarian Device Exemption Actually Requires

    A Humanitarian Device Exemption trades effectiveness proof for a population cap and IRB oversight — what that trade actually requires in practice.

    Connor Griggs · 3 min read
    A man in a black turtleneck reviews papers at a laptop against a wood-paneled wall
  4. Oct 202026
    Careers

    Generalist or Specialist: Choosing Your Regulatory Path

    Every regulatory career eventually forks between depth in one pathway and breadth across many — here is how that choice gets made, and sometimes unmade.

    Connor Griggs · 3 min read
    An older woman in a yellow blazer and glasses reads a stack of papers in an armchair surrounded by houseplants
  5. Oct 202026
    Craft

    What to Do When Your Predicate Device Gets Recalled

    A recalled predicate doesn’t erase a clearance already granted, but it changes what you can lean on next time — here is how FDA’s own guidance treats it.

    Connor Griggs · 3 min read
    A man in a gray sweater reads a stack of papers by a tall window, with a houseplant in the foreground
  6. Oct 202026
    Craft

    510(k) Summary or Statement: What You’re Committing To

    Every 510(k) must include a public summary or a statement promising the data on request — the choice carries consequences most submitters never weigh.

    Connor Griggs · 3 min read
    Two colleagues in white shirts stand together reading an open binder of printed pages in a bright office
  7. Oct 192026
    Craft

    How to Read a Field Alert Report

    A Field Alert Report runs on a three-working-day clock that starts when you learn of a problem, not when you confirm it — the mistake that trips people up.

    Connor Griggs · 3 min read
    A woman in a black dress reads a folder of colored charts at her desk, pen near her chin
  8. Oct 192026
    Careers

    Moving From FDA Into Industry Regulatory Affairs

    Leaving FDA for industry regulatory affairs means learning a new side of the same system, under real limits on what you can touch and who you can call.

    Connor Griggs · 4 min read
    An older woman in a white top reads a sheet of paper while standing by a tall bright window
  9. Oct 192026
    Craft

    What FDA Establishment Registration Actually Requires

    Registering a device establishment, and listing each device, are real legal deadlines — and by FDA’s own rule, neither one is an approval or endorsement.

    Connor Griggs · 4 min read
    A man in a black blazer reviews printed line charts at a desk beside an open laptop
  10. Oct 112026
    Craft

    Postmarketing Requirement vs. Postmarketing Commitment

    One label is a legal mandate with real penalties attached; the other is a written promise FDA enforces differently. Knowing which one you are reading matters.

    Connor Griggs · 4 min read
    A woman in a denim jacket looks up in thought while writing in a notebook, laptop open in front of her
  11. Oct 92026
    Careers

    How to Estimate a Regulatory Submission Timeline

    A 510(k)’s “90 days” and a PMA’s “180 days” are not the same kind of promise. Here is how FDA’s review clocks actually work, and how to turn one into a plan.

    Connor Griggs · 5 min read
    Two colleagues in blazers confer at a glass whiteboard in a bright office, one pointing with a marker toward faint notes
  12. Oct 82026
    Craft

    How to Read a Citizen Petition

    A citizen petition can flag a genuine safety problem, or try to stall a rival’s approval. FDA’s own rule for telling the two apart runs on a hard 150-day clock.

    Connor Griggs · 4 min read
    A man in a suit sits at a wooden desk reading a printed page while his other hand rests on a laptop keyboard
  13. Oct 82026
    Craft

    How to Read an FDA Drug Approval Letter

    An approval letter isn’t the finish line it feels like. Here’s what FDA is actually certifying under 21 CFR 314.105 and 601.4 — and what isn’t settled yet.

    Connor Griggs · 3 min read
    A woman in a red sweater smiles at the camera with a pen in hand, a laptop and papers on the desk in front of her
  14. Oct 82026
    Careers

    How Regulatory Affairs Works With Manufacturing

    A routine-looking manufacturing change can trigger a new 510(k) or NDA supplement. The relationship works when regulatory affairs catches that early.

    Connor Griggs · 4 min read
    Five colleagues gather around a white table reviewing sketches and notes together, one standing and pointing
  15. Oct 72026
    Careers

    Managing Up When Your Manager Isn’t Regulatory

    When your manager has never worked in regulatory, the job isn’t explaining the science. It’s translating a judgment call into something they can act on.

    Connor Griggs · 7 min read
    A smiling senior man in a gray suit sits in a sunlit chair holding open a red folder
  16. Oct 72026
    Craft

    How to Read a Special Protocol Assessment

    A Special Protocol Assessment locks in your Phase 3 trial design before you run it. Here’s what FDA is actually agreeing to, and what it isn’t.

    Connor Griggs · 7 min read
    A woman in a black blazer reviews a binder of tabulated data beside an open laptop at a white desk
  17. Oct 72026
    Craft

    How to Read a 505(b)(2) Application

    A 505(b)(2) application leans on someone else’s safety data instead of your own. 21 CFR 314.54 spells out exactly what that borrowing costs in return.

    Connor Griggs · 7 min read
    A woman rests her chin on her hand, looking intently at a laptop beside a rain-streaked office window overlooking a city
  18. Oct 62026
    Careers

    Moving From a CRO Into Sponsor-Side Regulatory Affairs

    A CRO’s obligations end at the contract. In-house, regulatory affairs owns the file indefinitely — 21 CFR 312.52 only transfers what the agreement describes.

    Connor Griggs · 6 min read
    A woman in a tan blazer sits with hands clasped, looking intently at a laptop in a meeting room
  19. Oct 62026
    Craft

    What Orphan Drug Designation Actually Changes

    Designation isn’t a fast track to approval. It’s a prevalence test under 21 CFR Part 316 that changes what a sponsor is entitled to, not FDA’s evidence bar.

    Connor Griggs · 6 min read
    A woman in a navy blazer works intently at a laptop against a white brick wall
  20. Oct 62026
    Craft

    How to Read a Clinical Study Report

    A clinical study report isn’t a results memo with tables attached — ICH E3 structures it as an argument a reviewer can evaluate without re-deriving the trial.

    Connor Griggs · 5 min read
    A woman in a white blazer reviews printed pages beside an open laptop in a bright conference room
  21. Oct 52026
    Craft

    How to Read a Periodic Safety Update Report

    A PSUR isn’t an annual report you file and forget. Under MDR Article 86 it has to tie post-market data to a benefit-risk conclusion a notified body reviews.

    Connor Griggs · 6 min read
    A woman in glasses works at a laptop, pen in hand beside an open notebook, with colorful sticky notes on the wall behind her
  22. Oct 42026
    Craft

    How to Work With a Notified Body Under EU MDR

    A notified body isn’t an auditor you pass once. Under MDR it holds ongoing authority over your technical file — including the right to show up unannounced.

    Connor Griggs · 7 min read
    A woman at a desk points a pen toward a laptop screen while holding a folder
  23. Oct 42026
    Careers

    Owning Your First Submission End to End

    The first time you own a submission, the hard part isn’t the writing. It’s becoming the person every other function waits on — and learns to trust.

    Connor Griggs · 6 min read
    A man presents a whiteboard plan to two seated colleagues in a bright office
  24. Oct 42026
    Craft

    How to Read a Form FDA 1572

    A Form FDA 1572 isn’t intake paperwork. Signing it commits an investigator to the protocol, the IRB, and FDA’s recordkeeping rules directly.

    Connor Griggs · 6 min read
    A woman reviews printed pages beside an open laptop at a bright kitchen counter
  25. Oct 22026
    Craft

    How to Read a Clinical Evaluation Report

    A Clinical Evaluation Report isn’t a literature summary. EU MDR requires it to conclude whether the clinical evidence actually supports the device.

    Connor Griggs · 6 min read
    Several adults sit at a table writing on printed documents in a bright, white-brick room with a large window
  26. Oct 22026
    Careers

    Giving Feedback to Someone You Manage

    Feedback from a manager carries weight a peer’s never does, which is exactly why vague, rare, or conflict-avoidant feedback does more damage than none at all.

    Connor Griggs · 5 min read
    A gray-haired man in a suit points to a hand-drawn chart on a flip chart while colleagues look on in a bright meeting room
  27. Oct 22026
    Craft

    How to Read a Master File Letter of Authorization

    A Letter of Authorization doesn’t hand over a Drug Master File — it tells FDA exactly what in someone else’s confidential file you may reference, and no more.

    Connor Griggs · 5 min read
    A man in glasses and a red tie leans over to help an older man review a document on a laptop in a library
  28. Oct 12026
    Craft

    How to Read an EUA Letter of Authorization

    An Emergency Use Authorization is not an approval or a clearance — it is a time-limited, revocable pathway with its own statutory criteria to meet.

    Connor Griggs · 5 min read
    A man takes off his glasses while studying a laptop screen in a bright, book-lined room
  29. Oct 12026
    Careers

    Moving From Clinical Affairs Into Regulatory Affairs

    Clinical affairs and regulatory affairs sit close together on an org chart, but the job itself changes more than the title suggests it would.

    Connor Griggs · 5 min read
    A man in glasses smiles at the camera at a desk with a laptop in a bright office
  30. Oct 12026
    Craft

    How to Read a PMA Supplement

    Not every change to an approved PMA device needs a new application. A supplement tells FDA what changed, and its type sets how much review is coming.

    Connor Griggs · 5 min read
    An older man reviews a laptop screen at a wooden desk with a notebook, pen, and plant beside him
  31. Sep 302026
    Craft

    How to Read an FDA Compliance Program Guidance Manual

    FDA investigators work from a public Compliance Program Guidance Manual for your inspection type — reading it first tells you what they’ll actually check.

    Connor Griggs · 5 min read
    A man in a white turtleneck studies a laptop screen and raises a pen while seated among colleagues in a bright office
  32. Sep 302026
    Careers

    How to Handle a Layoff or Reorg in Regulatory Affairs

    A layoff or reorg is disorienting, especially when regulatory affairs is a company’s only seat — what to check first, and how to keep moving forward.

    Connor Griggs · 5 min read
    A man sits in an armchair by a window, reading a laptop screen thoughtfully
  33. Sep 302026
    Craft

    How to Read an FDA Certificate to Foreign Government

    A Certificate to Foreign Government tells an importing country your product is legally marketed in the US — what it actually verifies, and what it doesn’t.

    Connor Griggs · 5 min read
    A woman in a navy blazer reviews printed documents at a bright desk with a laptop and a pink mug
  34. Sep 292026
    Craft

    How to Build a Design Control Traceability Matrix

    A traceability matrix links every user need to a design input, output, and test record — what belongs in one, and why reviewers ask for it before anything else.

    Connor Griggs · 5 min read
    A woman in a light blue blouse reviews printed documents and a folder at a bright desk with a lamp and a calculator
  35. Sep 292026
    Careers

    How to Work With a Regulatory Affairs Recruiter

    A recruiter is paid to fill a role, not manage your career — knowing which kind you’re talking to, and what to tell them early, makes the relationship useful.

    Connor Griggs · 5 min read
    Two women sit at a conference table, one smiling broadly, with water bottles and folders in front of them
  36. Sep 292026
    Craft

    How to Submit a Public Comment on FDA Draft Guidance

    Anyone can comment on FDA draft guidance, not just regulated companies — what makes a comment worth reading, and the mechanics of actually filing one.

    Connor Griggs · 5 min read
    A man in glasses smiles while typing on a laptop at a bright desk in a warm-toned room
  37. Sep 282026
    Craft

    How to Read an FDA Warning Letter Close-Out Letter

    A close-out letter tells the public FDA considers a warning letter resolved — it is not proof of full compliance, and reading it as one is the mistake to avoid.

    Connor Griggs · 5 min read
    A woman in a black shirt writes in a notebook at a desk with binders and an open laptop, with a city skyline through the window behind her
  38. Sep 282026
    Careers

    How to Interview a Regulatory Affairs Candidate

    Interviewing a regulatory affairs candidate well means testing judgment under ambiguity, not a resume — what to ask, and what the answers actually reveal.

    Connor Griggs · 5 min read
    Three colleagues talk and smile around a desk in an office, with a flip chart showing a simple diagram in the background
  39. Sep 282026
    Careers

    How to Write a Regulatory Affairs Cover Letter

    A regulatory affairs cover letter earns attention by naming one decision you made, not by restating your resume — what actually belongs in the three paragraphs.

    Connor Griggs · 5 min read
    A woman in a black top leans over a laptop at a desk covered in papers, typing with one hand
  40. Sep 272026
    Craft

    How to Read an FDA Consent Decree

    A consent decree is a federal court order a company agrees to, not an admission of guilt — here is what its terms actually commit a firm to do.

    Connor Griggs · 6 min read
    A man in a black suit sits on a leather couch reading a printed document, with a bookshelf of books in the background
  41. Sep 272026
    Craft

    How to Read an IRB Approval Letter

    An IRB approval letter authorizes one protocol and consent version, not a study in general, and it expires on its own if continuing review lapses.

    Connor Griggs · 5 min read
    A man in a gray suit sits in an office chair, smiling while reading a printed letter
  42. Sep 272026
    Careers

    Moving From Regulatory Affairs Into Medical Writing

    Regulatory affairs already trains the skill medical writing pays for: writing to evidence. What transfers, what doesn’t, and how to test it first.

    Connor Griggs · 5 min read
    A woman in a white blazer sits at a glass desk writing in a notebook beside an open laptop, with a window in the background
  43. Sep 262026
    Careers

    Regulatory Strategy vs. Regulatory Operations

    Strategy sets the pathway and argues it to FDA; operations builds and files the submission that carries it. Picking a lane shapes years of your career.

    Connor Griggs · 5 min read
    A woman in a floral dress sits at a desk working on a laptop beside a window, with a whiteboard covered in colorful sticky notes in the background
  44. Sep 262026
    Careers

    How Regulatory Affairs Works With Legal

    Regulatory reads a claim against what was cleared; legal reads it against what could be sued over. The overlap is real, and so is the gap between them.

    Connor Griggs · 5 min read
    Three colleagues lean over a table covered in printed flowcharts and notes, two seated and one standing, in a collaborative discussion
  45. Sep 262026
    Craft

    How to Read a Letter-to-File Decision

    Most device changes never reach FDA — a manufacturer decides internally, in writing, whether a change needs a new 510(k) or just a documented rationale.

    Connor Griggs · 5 min read
    A man in a tweed blazer reviews a printed document at his desk, pen in hand, laptop open beside him
  46. Sep 252026
    Careers

    How to Know When to Leave a Regulatory Affairs Job

    Burnout, a bad manager, and a stalled career look similar from the inside. Separating them tells you whether to fix the job, wait it out, or start looking.

    Connor Griggs · 5 min read
    A man in a dark shirt smiles while taking notes at a desk beside an open laptop, looking toward a window
  47. Sep 252026
    Careers

    How Regulatory Affairs Works With Marketing

    Marketing wants a claim that sells; regulatory confirms it says only what was cleared or approved — catching the gap early is cheaper than after launch.

    Connor Griggs · 5 min read
    A colleague gestures while presenting to three seated colleagues around a conference table in a vaulted meeting room
  48. Sep 252026
    Craft

    How to Read a PMA Annual Report

    A PMA doesn’t end at approval — the periodic report is where a manufacturer shows the device still matches what FDA approved, before an inspector notices drift.

    Connor Griggs · 5 min read
    A woman writes closely in a notebook at a glass desk beside an open laptop
  49. Sep 242026
    Careers

    When You Disagree With Your Manager’s Strategy

    Most of these are a risk-appetite difference, not a rules violation — how you handle being overruled shapes whether your manager wants your view next time.

    Connor Griggs · 5 min read
    Two colleagues review a document together in an office, one gesturing while pointing at a page
  50. Sep 242026
    Craft

    How to Read a Device Master Record

    The DMR isn’t the design history file — it’s the current, approved recipe a manufacturing line builds from, and it protects you only if it stays current.

    Connor Griggs · 5 min read
    A man works closely at a laptop against a plain white office wall, a small potted plant on the desk beside him
  51. Sep 242026
    Craft

    How to Read an FDA Clinical Hold Letter

    A clinical hold isn’t a rejection — it’s an order to stop specific activities until specific deficiencies are resolved. Reading which ones is the job.

    Connor Griggs · 5 min read
    A woman studies her laptop screen closely at a desk in a high-rise office, a badge on a lanyard around her neck
  52. Sep 232026
    Careers

    Is a Master’s in Regulatory Affairs Worth It?

    It isn’t a credential any agency requires or recognizes. Who actually gets value from the degree, and when real submission experience is the better investment.

    Connor Griggs · 5 min read
    A man in a suit works on a laptop outdoors near modern office towers, an employee badge visible on a lanyard
  53. Sep 232026
    Careers

    How Regulatory Affairs Works With Clinical

    Regulatory keeps the IND current; clinical runs the trial. Here’s where that division of labor sits, and where a missed handoff turns into a reportable problem.

    Connor Griggs · 5 min read
    Two colleagues sit together reviewing a red folder, one pointing to a page while the other looks on
  54. Sep 232026
    Craft

    How to Read an IND Application

    An IND application isn’t a safety file — it’s an argument that the nonclinical data support a specific dose, protocol, and population. Here’s what to check.

    Connor Griggs · 5 min read
    A man works intently on a laptop at an empty conference table, papers and earbuds within reach
  55. Sep 222026
    Careers

    Moving From Regulatory Affairs Into Quality

    Regulatory affairs builds the argument; quality verifies the evidence and owns the system that produces it. What transfers when you move, and what doesn’t.

    Connor Griggs · 6 min read
    A woman in a blazer looks down in thought while seated in an office lobby
  56. Sep 222026
    Craft

    How to Read an IND Annual Report

    An IND annual report isn’t a bigger safety report — it’s the once-a-year synthesis of a program, and the investigational plan repays the closest reading.

    Connor Griggs · 5 min read
    A woman reads closely from an open book while standing in an empty conference room
  57. Sep 202026
    Careers

    How to Onboard Yourself When Nobody Else Will

    Nobody handed you a plan? Read the regulation itself, not just the SOP that cites it, and map who actually knows what before you wait for someone else to.

    Connor Griggs · 5 min read
    A woman in a yellow blazer and glasses looks closely at an open laptop while seated in an armchair
  58. Sep 182026
    Careers

    How to Mentor Someone Newer Than You in Regulatory Affairs

    Being reachable isn’t the same as being useful. What actually helps a junior colleague grow is showing your reasoning, not just handing over your answer.

    Connor Griggs · 5 min read
    A man in glasses and a sweater and tie sits on a sofa working on a laptop, looking up in thought
  59. Sep 182026
    Craft

    How to Read an IND Safety Report

    An IND safety report only applies to events that are serious, unexpected, and plausibly drug-caused — not every adverse event qualifies. Here’s how it works.

    Connor Griggs · 5 min read
    A woman types on a laptop at a desk with open handwritten notebooks in front of her
  60. Sep 182026
    Craft

    How to Read a REMS

    A REMS attaches real restrictions to how a drug gets prescribed or dispensed — not every element applies to every drug. Here’s what to check first.

    Connor Griggs · 5 min read
    A woman with gray hair and glasses works at a laptop at a conference table in an office, a plant in the foreground
  61. Sep 172026
    Careers

    How Regulatory Affairs Works With Quality

    Regulatory and quality run on the same records but answer different questions. Here’s where that split falls, and where it breaks without a shared file.

    Connor Griggs · 5 min read
    A man in a tweed jacket sits holding an open notebook and a pen, looking off to the side in thought
  62. Sep 172026
    Craft

    How to Read a CAPA

    A CAPA has to show a correction addressed the actual cause, not just the symptom, and that someone verified it worked. Here’s what a defensible one contains.

    Connor Griggs · 5 min read
    A woman in a black blazer writes closely in a bound notebook at a desk, with a printed form and a coffee cup nearby
  63. Sep 172026
    Craft

    How to Read a Biocompatibility Evaluation Report

    A biocompatibility file isn’t a checklist of passed tests — it’s an argument for why those were the right tests for this device. Here’s how to read one.

    Connor Griggs · 5 min read
    A woman leans over a desk with binders and a laptop, reviewing a thick stack of printed pages
  64. Sep 162026
    Craft

    How to Read a Complaint File

    A complaint file has to do two things: capture what the customer actually said, and show your reasoning for whether it was reportable. Here’s how to read one.

    Connor Griggs · 5 min read
    A man in a vest and tie stands in profile against a plain office wall, glasses on, mid-sentence
  65. Sep 162026
    Careers

    How to Advance in Regulatory Affairs Without Managing

    Staying an individual contributor doesn’t mean staying in place. What actually has to change for the next title to make sense with no headcount to point to.

    Connor Griggs · 4 min read
    A woman gestures while pointing at a whiteboard, seen past the shoulder of a colleague listening in the foreground
  66. Sep 152026
    Craft

    How to Read a Device Cybersecurity Submission

    Cybersecurity documentation is now required in many device submissions. Here’s what the package has to show, and what a thin one looks like to a reviewer.

    Connor Griggs · 5 min read
    Four colleagues lean over a table covered in printed plans and sketches, collaborating closely
  67. Sep 152026
    Craft

    How to Read a Risk Management File

    A risk management file is supposed to prove every hazard traces to a control that actually works. Here’s what holds that chain together, and what breaks it.

    Connor Griggs · 6 min read
    An older woman and a man in business suits stand reviewing an open folder together, one pointing at a page
  68. Sep 152026
    Careers

    How to Onboard a New Regulatory Affairs Hire

    Onboarding a new regulatory hire well means compressing months of context into weeks without dumping it all on day one. Here’s what to hand them, and when.

    Connor Griggs · 4 min read
    A senior colleague and a younger colleague review a printed document together at a desk, with a laptop open nearby
  69. Sep 142026
    Craft

    How to Write a Submission Handoff Someone Else Can Use

    A regulatory handoff is the last artifact you produce in a role. What needs to be in it, and why most fail the person who inherits the work.

    Connor Griggs · 5 min read
    Two colleagues shake hands over an exchanged folder in a conference room with a city view
  70. Sep 142026
    Craft

    How to Read a Human Factors Validation Report

    A validation report is supposed to prove real users can operate the device safely. What it has to connect, and what a thin one looks like.

    Connor Griggs · 6 min read
    A woman in a pale pink sweater points a marker at a whiteboard while explaining something
  71. Sep 142026
    Careers

    How to Evaluate a Regulatory Affairs Team Before You Join

    An offer letter tells you the salary and the title. It doesn’t tell you whether the team has the standing to let you do the job well.

    Connor Griggs · 5 min read
    Two men in suits sit at a desk, one gesturing while the other points a pen at a tablet showing a chart
  72. Sep 132026
    Careers

    Building a Body of Work When It’s All Confidential

    You can’t show anyone the submissions you actually worked on. What still proves you can do the job — and how to talk about work you can’t describe in detail.

    Connor Griggs · 5 min read
    A woman in a light green sweater looks intently at an open laptop while working at a desk
  73. Sep 132026
    Craft

    How to Read a PMA Refuse-to-File Decision

    A PMA can be refused before FDA ever reviews the science. What triggers a Refuse-to-File decision, how it differs from a 510(k) RTA, and what to do with one.

    Connor Griggs · 5 min read
    A woman wearing glasses holds a pen and looks thoughtfully to the side near a sunlit window
  74. Sep 132026
    Craft

    How to Read Your FDA Pre-Submission Meeting Minutes

    The meeting itself is informal; the minutes are the record. What FDA’s Q-Submission meeting minutes actually commit you to, and how to read them before you act.

    Connor Griggs · 5 min read
    A man raises his hand to ask a question during a seminar, colleagues seated nearby
  75. Sep 122026
    Craft

    What EU MDR Requires That FDA Doesn’t

    The EU MDR runs on a different reviewer, a different accountability structure, and a different relationship to clinical evidence than the FDA’s device pathways.

    Connor Griggs · 5 min read
    A woman in a white blouse holds a pen at a desk, an open laptop and notebook in front of her
  76. Sep 122026
    Craft

    How to Read a Design History File

    A Design History File isn’t one document but a chain of evidence — what it has to prove, and how to read it the way an FDA investigator or a new hire would.

    Connor Griggs · 5 min read
    A woman in a red sweater writes in a notebook at a desk, an open laptop and a stack of old books beside her
  77. Sep 122026
    Careers

    How to Change Companies in Regulatory Affairs

    Pathway judgment travels between employers. Process and relationships don’t. What to expect when you change companies, and how to leave well.

    Connor Griggs · 5 min read
    A woman wearing glasses smiles while writing in a notebook beside an open laptop
  78. Sep 112026
    Craft

    What the QMSR Actually Changes

    The Quality Management System Regulation replaced 21 CFR 820’s old language with ISO 13485:2016 by reference. What changed, and what stayed the same.

    Connor Griggs · 5 min read
    A woman sits by a tall window, writing in a notebook while an open laptop rests on a low table
  79. Sep 112026
    Craft

    How to Read a PMA Summary of Safety and Effectiveness Data

    A PMA’s Summary of Safety and Effectiveness Data is FDA’s public record of why a device was approved — read it well, and know what it leaves out.

    Connor Griggs · 5 min read
    A woman in a white shirt sits at a desk by a window, writing in a notebook beside an open laptop
  80. Sep 112026
    Careers

    How to Build the Case for a Promotion

    A promotion in regulatory affairs rarely arrives on schedule. What to track between reviews, how to learn what the next level requires, and how to ask.

    Connor Griggs · 5 min read
    A smiling woman at a desk with a laptop and a stack of old books writes in a small notebook
  81. Sep 22026
    Craft

    How to Review a Colleague’s Regulatory Draft

    A colleague’s draft deserves more than “looks good.” What a useful reviewer actually checks, and how to write comments the author can act on.

    Connor Griggs · 5 min read
    A colleague’s hands annotate a notebook beside an open laptop, notepad, and papers on a desk
  82. Sep 12026
    Craft

    How to Brief a Team on a New FDA Requirement

    A new FDA requirement means nothing to your team until you translate it into what changes for their program, by when, and who has to act on it.

    Connor Griggs · 5 min read
    A presenter sketches on a flip chart while two colleagues look on by a window
  83. Sep 12026
    Craft

    How to Run a Submission Readiness Review

    A readiness review is the last honest look before you submit, not a repeat of the RTA checklist. What it actually checks, and who belongs in the room.

    Connor Griggs · 5 min read
    Three colleagues review printed charts and an open laptop together at a conference table
  84. Sep 12026
    Careers

    How to Push Back on a Launch Timeline You Didn’t Set

    Regulatory doesn’t set FDA’s review clock, but pretending the whole timeline is out of your hands wastes your credibility. What to say instead.

    Connor Griggs · 5 min read
    Two colleagues talk over papers at a table with a bar chart shown on a screen behind them
  85. Aug 312026
    Craft

    How to Read a Federal Register Notice

    A Federal Register notice is not the regulation itself, and reading it like one wastes time. Where to look first, and what a docket number unlocks.

    Connor Griggs · 5 min read
    An open laptop and notebook on a wooden desk beside a pair of glasses
  86. Aug 302026
    Craft

    What Breakthrough Device Designation Actually Changes

    Breakthrough Devices Program designation buys FDA’s attention and priority review, not a lower bar for clearance. What actually changes, and what doesn’t.

    Connor Griggs · 5 min read
    A man writes in a notebook beside an open laptop and a cup of coffee at a low table
  87. Aug 292026
    Careers

    Being the Only Regulatory Voice in the Room

    Being the only regulatory voice in a fast-moving room means separating what’s required from what’s your call. How to hold that line without losing the room.

    Connor Griggs · 6 min read
    A man laughs while seated with colleagues at tables during a meeting
  88. Aug 292026
    Craft

    Writing an Indications for Use Statement You Can Defend

    An indications for use statement quietly sets the boundary of your 510(k). How to write one your testing actually supports, and defend it after clearance.

    Connor Griggs · 6 min read
    A hand writes on a printed worksheet beside an open laptop on a desk
  89. Aug 292026
    Craft

    How to Read an FDA Advisory Committee Transcript

    An advisory committee’s vote is FDA’s input, not its decision. How to read the transcript for the concerns and phrasing most likely to shape what happens next.

    Connor Griggs · 6 min read
    A man writes closely in a notebook in a red-seated lecture hall
  90. Aug 282026
    Craft

    Handling a Regulatory Decision You Disagree With

    Disagreeing with a regulatory determination is normal; how you raise it shapes your credibility. A practical way to make your case, then know when to let it go.

    Connor Griggs · 5 min read
    A row of professionals wearing lanyards sit and listen attentively during a meeting
  91. Aug 282026
    Careers

    Your First Regulatory Affairs Performance Review

    Your first performance review rewards work that’s easy to miss from outside the function. How to document what you decided, before the conversation happens.

    Connor Griggs · 5 min read
    A woman with a notebook and pencil sits at a table with open laptops during a discussion
  92. Aug 282026
    Craft

    Responding to an FDA Additional Information Request

    An FDA Additional Information request pauses your submission, not your case. How to answer exactly what’s asked without reopening what’s already settled.

    Connor Griggs · 5 min read
    A woman works focused at a laptop in a minimalist office
  93. Aug 272026
    Careers

    How to Run a Study Group for the RAC Exam

    Studying alone for the RAC exam works until it doesn’t. How to structure a small peer study group so it forces retrieval and exposes blind spots.

    Connor Griggs · 6 min read
    A woman addresses three seated colleagues during a discussion among library shelves
  94. Aug 262026
    Craft

    Building a Working File of Predicate and Precedent Devices

    Bookmarking 510(k) summaries isn’t the same as building expertise. How to keep a working file of predicate devices that gets more useful every time you use it.

    Connor Griggs · 7 min read
    A woman writes in a notebook while referencing an open book at a desk
  95. Aug 262026
    Careers

    Teaching a Colleague What Regulatory Affairs Actually Does

    A short, honest session on what regulatory affairs actually owns changes how engineers and other colleagues work with you — far more than a lecture on the CFR.

    Connor Griggs · 6 min read
    A woman presents at a whiteboard while a colleague listens in an office
  96. Aug 262026
    Craft

    Giving a Regulatory Update Executives Will Actually Use

    A status update that lists activity instead of decisions won’t get read twice. What a submission update should say, and what can wait for the next one.

    Connor Griggs · 6 min read
    A man holds a tablet and gestures while addressing a small seated group in a meeting room
  97. Aug 252026
    Careers

    The First Regulatory Affairs Hire

    What changes when you’re the only regulatory affairs person at a company, with no existing function, no playbook, and no one to calibrate against.

    Connor Griggs · 6 min read
    A woman leans over a laptop at a kitchen counter beside an open book
  98. Aug 252026
    Craft

    How to Read an MDSAP Audit Report

    A single MDSAP audit can satisfy five regulators at once. How the report is structured, how findings are graded, and what a clean one doesn’t tell you.

    Connor Griggs · 6 min read
    A woman writes in a notebook while reviewing something on a laptop at an evening desk
  99. Aug 252026
    Craft

    How to Write a Response to an FDA Warning Letter

    A warning letter response isn’t a corrective action plan with a cover page. What FDA is actually evaluating, and why the signature on it matters.

    Connor Griggs · 6 min read
    A man wearing glasses writes in a notebook at a home desk beside an open laptop
  100. Aug 242026
    Craft

    How to Read an FDA Postmarket Surveillance Order

    A postmarket surveillance order isn’t a penalty. It’s FDA requiring a study after clearance, tied to Section 522 — and what the order asks a manufacturer to do.

    Connor Griggs · 7 min read
    A woman wearing headphones reviews documents and types on a laptop at a desk with markers and an open notebook
  101. Aug 242026
    Craft

    How to Read an FDA Safety Communication

    An FDA safety communication carries no legal force of its own. What one actually is, why FDA issues them, and how a practitioner should read one correctly.

    Connor Griggs · 6 min read
    A woman rests her chin in her hand while reading something on a laptop beside an open notebook
  102. Aug 242026
    Careers

    How to Work With a Regulatory Affairs Consultant

    Hiring a regulatory consultant doesn’t move the responsibility off your desk. How to scope the engagement, and what a consultant can’t take off your plate.

    Connor Griggs · 6 min read
    Two colleagues in a workshop setting, one writing notes on a pad and the other gesturing while speaking
  103. Aug 232026
    Craft

    How to Read an FDA Establishment Inspection Report

    A Form 483 lists what an investigator observed. The Establishment Inspection Report is FDA’s own narrative behind it, and getting one takes a records request.

    Connor Griggs · 7 min read
    A man writes in a notebook at a wooden table surrounded by office plants
  104. Aug 232026
    Craft

    How to Read an FDA Not Substantially Equivalent Letter

    An NSE letter doesn’t end a 510(k) pathway — it forecloses one predicate comparison. What the letter says, and the three ways forward after it.

    Connor Griggs · 6 min read
    A senior man in a white shirt reviews handwritten notes beside an open laptop
  105. Aug 232026
    Careers

    Startups vs. Established Companies in Regulatory Affairs

    Neither path is inherently better for a regulatory affairs career — what changes is the pace, the mentorship, and how early you're trusted with real scope.

    Connor Griggs · 6 min read
    A man in a blue shirt reads an open book at a white desk beside a lamp and a small potted plant
  106. Aug 222026
    Careers

    Building expertise in one product area

    Depth in one product area compounds faster than breadth ever does early on — what that actually means when you rarely get to choose the assignment.

    Connor Griggs · 5 min read
    A woman wearing headphones writes in a notebook beside an open laptop at a desk
  107. Aug 222026
    Craft

    How to read an FDA 513(g) response

    A 513(g) response tells you how FDA would classify a device — it is not a clearance, and reading it as one is the most common way this document gets misused.

    Connor Griggs · 6 min read
    A woman in a white shirt writes in a notebook at a wooden table beside an open laptop
  108. Aug 222026
    Craft

    How to read an FDA import alert

    An import alert puts a firm’s shipments on detention before they reach a review — what triggers one, how DWPE works, and how a listing actually gets removed.

    Connor Griggs · 6 min read
    An older woman in a blazer reviews handwritten notes beside an open laptop
  109. Aug 212026
    Craft

    How to read an FDA advisory committee briefing

    Before a panel votes, FDA and the sponsor each publish a briefing document — what the two documents contain, and where they tend to disagree.

    Connor Griggs · 7 min read
    A woman in a blazer writes in a notebook at a desk beside an open laptop, glasses set to one side
  110. Aug 212026
    Craft

    How to read an FDA notice of inspection

    Form FDA 482 is what an investigator presents at your door under Section 704 of the FD&C Act — what it establishes, and what to do in the first hour.

    Connor Griggs · 6 min read
    A man wearing glasses writes in a notebook beside an open laptop and a cup of coffee
  111. Aug 212026
    Careers

    How to negotiate a regulatory affairs job offer

    Compensation is usually fixed by the time an offer lands. Start date, level, relocation, and exam support often are not — what to ask for, and how to ask.

    Connor Griggs · 6 min read
    A man in a shirt and tie writes in a notebook at a desk beside an open laptop in a modern office
  112. Aug 202026
    Craft

    The case for keeping a regulatory decision log

    A running record of the small judgment calls you make is worth more than memory once an audit or a new hire needs to understand how you got there.

    Connor Griggs · 5 min read
    A close view of hands writing in a spiral notebook at a desk beside an open laptop and a phone, no face visible
  113. Aug 202026
    Careers

    How to get value from a regulatory affairs conference

    The sessions matter less than the conversations. What a trade conference rewards is different from what an FDA public meeting or a paid course rewards.

    Connor Griggs · 5 min read
    A blurred seminar audience seen past an unfocused foreground
  114. Aug 192026
    Craft

    How to read an FDA inspection classification

    A Form FDA 483 lists observations. The classification that follows — NAI, VAI, or OAI — is what actually determines whether the story ends there.

    Connor Griggs · 7 min read
    A man rests a pen against his chin, reading closely from a laptop screen
  115. Aug 192026
    Craft

    How to write an FDA 483 response

    A 483 response isn’t a form to fill out. It’s a technical document that shapes whether FDA classifies the inspection as VAI or moves toward a Warning Letter.

    Connor Griggs · 7 min read
    A person writes in a notebook resting on their lap, a lanyard visible at the collar, a coffee cup and laptop nearby
  116. Aug 192026
    Careers

    How regulatory affairs works with R&D

    Regulatory affairs earns influence with engineering by showing up during design, not just at the end. Design controls give both functions a shared language.

    Connor Griggs · 6 min read
    Three colleagues sit working independently at laptops in a bright shared office space
  117. Aug 182026
    Craft

    How FDA decides which center reviews your product

    Combination products don’t pick their own review center. A Request for Designation is how a sponsor gets a binding answer instead of a guess.

    Connor Griggs · 7 min read
    A gray-haired man sits in a library reading closely from a book, a stack of reference volumes beside him
  118. Aug 182026
    Careers

    Moving from individual contributor to RA manager

    The judgment that made you a strong specialist doesn’t automatically transfer once you’re responsible for someone else’s. What actually changes.

    Connor Griggs · 7 min read
    A woman in a dark blazer stands writing on a notepad while a colleague sits nearby in a bright office
  119. Aug 182026
    Craft

    How to read an FDA Untitled Letter

    An Untitled Letter cites a real violation, without the deadline and escalation language a warning letter carries. Reading the difference correctly matters.

    Connor Griggs · 6 min read
    A close-up of a hand annotating a letter with a pen, an ID badge on a lanyard visible at the wrist
  120. Aug 172026
    Craft

    How to read a predetermined change control plan

    FDA can pre-authorize a defined set of future device changes inside the original submission. What a change control plan promises, and where its authority stops.

    Connor Griggs · 8 min read
    A close overhead view of a person's hands writing in a spiral notebook beside an open laptop and a cup of pencils
  121. Aug 172026
    Careers

    What changes when you consult in regulatory affairs

    The regulatory reasoning barely changes moving from in-house to consulting. What shifts is who owns the client relationship, the deadline, and the outcome.

    Connor Griggs · 7 min read
    A gray-haired man in a blazer leans over a standing desk, writing in a notebook beside a monitor and an adjustable desk lamp
  122. Aug 172026
    Craft

    How to read a device’s UDI record in GUDID

    Every device carries a Unique Device Identifier, and FDA publishes what it means in a public database. What its two halves tell you, and what they don’t.

    Connor Griggs · 7 min read
    A man in a blue shirt sits at a white desk reading closely from an open book, a phone and potted plant nearby
  123. Aug 162026
    Craft

    How to read an FDA complete response letter

    When FDA finishes reviewing a drug application and the answer isn’t yes, it sends a Complete Response Letter instead of an approval letter. What that letter is built to do, and why you’ll rarely read the document itself.

    Connor Griggs · 7 min read
    An overhead view of a person writing notes in a spiral notebook beside an open laptop
  124. Aug 162026
    Craft

    How to read an FDA De Novo classification order

    When a novel, low-to-moderate-risk device has no predicate to compare against, FDA can grant it market authorization directly. What the resulting order actually says, and what it means for the next sponsor who reads it.

    Connor Griggs · 8 min read
    A man in a vest and tie sits reading closely from an open notebook at his desk beside a computer monitor
  125. Aug 162026
    Careers

    From the bench to regulatory affairs

    A research background gives you real, useful skills for this work — just not always the ones people assume, and not without some translation. What actually transfers, and what you have to learn from scratch.

    Connor Griggs · 7 min read
    A woman with curly hair sits at a table writing closely in a notebook, an open book and papers spread in front of her
  126. Aug 152026
    Craft

    How to get value from an FDA public meeting

    Advisory committee meetings and public workshops are open to attend, and sometimes to speak at. What they’re actually for, and the difference between a public meeting and a conversation about your own submission.

    Connor Griggs · 8 min read
    A row of seminar attendees wearing lanyards sit taking notes while listening in a bright meeting room
  127. Aug 152026
    Craft

    How to read FDA’s IDE regulations

    Before a device reaches the market, someone has to decide it is safe enough to study on people first. What an Investigational Device Exemption actually requires, and who makes that call.

    Connor Griggs · 8 min read
    A woman wearing headphones writes in a notebook at a desk beside an open laptop and notepad
  128. Aug 142026
    Craft

    How to read FDA’s RTA checklist

    Before anyone reviews the substance of your 510(k), someone checks whether it’s complete enough to review at all. What that first pass actually looks for.

    Connor Griggs · 7 min read
    A woman in a blazer writes in a notebook while reviewing a laptop screen at an office desk
  129. Aug 142026
    Craft

    How to read FDA’s eSTAR submission template

    eSTAR isn’t just a form to fill out — its structure previews how a reviewer will work through your file, long before they open it.

    Connor Griggs · 7 min read
    A woman sits at a desk with an open laptop, writing in a notebook beside a cup of coffee and a stack of books
  130. Aug 142026
    Careers

    Building a work sample with no RA experience

    You can’t point to a track record you don’t have yet. How to build something concrete that shows the judgment a hiring manager is actually screening for.

    Connor Griggs · 7 min read
    A young woman sits at an outdoor table writing in a notebook with a pencil, a laptop open beside her
  131. Aug 132026
    Careers

    The regulatory affairs career ladder, explained

    Associate, specialist, manager — titles change, but what earns the next one is judgment, not tenure. What shifts at each rung, and how to tell you’re ready.

    Connor Griggs · 7 min read
    A man writes notes in a spiral notebook at an office desk beside a desktop monitor and keyboard
  132. Aug 132026
    Craft

    How to prepare for an FDA pre-submission meeting

    A Pre-Sub is one chance to get FDA’s read before you build the file. What to bring, what to ask, and how the feedback actually gets used.

    Connor Griggs · 7 min read
    A man writes in a notebook in a book-lined room while colleagues work nearby
  133. Aug 132026
    Craft

    How to read an FDA product classification entry

    Every cleared device carries a product code that unlocks its regulatory history. How to read a classification entry, and what each field tells you.

    Connor Griggs · 7 min read
    A man wearing glasses annotates a printed chart with a pen while working beside an open laptop
  134. Aug 82026
    Careers

    How to choose a regulatory affairs certificate program

    A certificate program’s landing page sells an outcome. Only the syllabus shows what you’ll actually learn — and whether it’s built for the job you want.

    Connor Griggs · 8 min read
    A woman with glasses and gray-streaked hair looks down in concentration, wearing a white blouse, with softly blurred wood paneling and a window behind her
  135. Aug 72026
    Craft

    How to read a medical device report

    MAUDE is public and searchable, and a report in it is an allegation, not a finding. Read the coded fields as an index, not a diagnosis.

    Connor Griggs · 7 min read
    A close-up of a person's hand turning a page in a hardcover book beside a spiral notepad and pen
  136. Aug 72026
    Craft

    How to read an FDA recall

    A recall notice looks alarming and is almost always mundane. What the Class I, II, and III label is actually measuring — and what it isn’t.

    Connor Griggs · 7 min read
    A gavel and a small blind-justice statuette holding scales, on a green desk pad in front of a dark wood bookshelf lined with law books
  137. Aug 72026
    Careers

    Continuing education in regulatory affairs

    A credential earned once goes stale the moment the rule underneath it changes. The free channels, the tracking habit, and why training has to leave a record.

    Connor Griggs · 6 min read
    Rows of empty vintage lecture hall seats with tablet armrests, ceiling fans, and arched windows in the background
  138. Aug 62026
    Craft

    How to write a regulatory rationale you can defend

    A rationale isn’t finished when it reads well. It’s finished when it survives someone trying to take it apart.

    Connor Griggs · 7 min read
    Two hardcover books, the top one embossed LAW in raised letters, stacked on a plain white surface
  139. Aug 62026
    Careers

    Moving from quality into regulatory affairs

    A quality background covers more regulatory ground than the job title suggests — but the move asks for a skill quality work doesn’t train.

    Connor Griggs · 7 min read
    A person reviews a handwritten notebook with a pen in hand beside an open laptop showing an email inbox
  140. Aug 62026
    Careers

    How to read a regulatory affairs job posting

    Regulatory affairs job postings use inconsistent titles and requirement lists. Here’s how to read one closely before you apply.

    Connor Griggs · 7 min read
    A pair of hands writes in an open leather notebook with a pen, an employee ID badge visible on a lanyard below
  141. Aug 52026
    Craft

    How to build a regulatory intelligence habit

    Tracking regulatory change is a habit built over a career, not a project you finish once and move on from.

    Connor Griggs · 6 min read
    A woman in a hijab writes in a notebook beside an open laptop and a coffee cup at a café table
  142. Aug 52026
    Craft

    How to read a 510(k) summary

    FDA publishes a public summary for every 510(k) clearance. Here’s what it can tell you, and what it leaves out.

    Connor Griggs · 7 min read
    A woman in a blazer reads a printed document closely while standing in a home office, a pen tucked behind her ear
  143. Aug 52026
    Careers

    Your first 90 days in regulatory affairs

    The first ninety days in a new regulatory affairs role are for orientation, not output.

    Connor Griggs · 7 min read
    A man at a home desk reviews a document in an open folder while writing, with a laptop open in front of him
  144. Aug 42026
    Careers

    Getting value from a regulatory affairs course

    Enrolling in a course is easy. Getting real value from it takes more deliberate effort than just showing up and taking notes.

    Connor Griggs · 6 min read
    A man stands at the center of a semicircle of classroom desks, holding a printed handout, while three seated participants turn to listen during a group discussion
  145. Aug 32026
    Craft

    How to get a useful review of your draft

    A draft no one but its author has read is not ready to submit. How to ask for a review that finds a real problem, instead of one that just signs off on it.

    Connor Griggs · 7 min read
    Two colleagues look closely at a laptop screen together at a desk, one seated and typing while the other leans in and points
  146. Aug 32026
    Careers

    How to study for the RAC exam

    Deciding to sit for the RAC is one question. Studying for it is another — a routine built around scenarios and primary sources, not flashcards.

    Connor Griggs · 7 min read
    A woman studies late at night at a library table stacked with books and a laptop, rows of bookshelves behind her
  147. Aug 32026
    Craft

    How a regulation actually changes

    A regulation does not change the moment an agency decides it should. The rulemaking process, and why the effective date is rarely the whole story.

    Connor Griggs · 7 min read
    A hand writes a numbered list on a spiral notepad with a marker, two pens resting nearby on a sunlit wooden desk
  148. Aug 22026
    Craft

    How to read a Form FDA 483

    The observations on a 483 are an investigator’s judgment, not a verdict — and the response you write in the days after usually matters more than what is written on the form.

    Connor Griggs · 7 min read
    A close-up of a hand annotating handwritten notes in a spiral notebook with a pen, seen over the writer’s shoulder
  149. Aug 22026
    Craft

    How to read a recognized consensus standard

    Citing a consensus standard from memory is not the same as checking what FDA’s recognition entry for it actually covers today. How to read one closely enough to know the difference.

    Connor Griggs · 7 min read
    An overhead view of a person wearing headphones cross-referencing an open dictionary while writing in a notebook beside a laptop
  150. Aug 22026
    Careers

    Building a professional network in regulatory affairs

    A network built only during a job search reads exactly like what it is. How to build professional relationships in regulatory affairs starting with the people already in the room.

    Connor Griggs · 7 min read
    A person types on a laptop beside an annotated notebook, in front of a bookshelf, seen over their shoulder
  151. Aug 12026
    Craft

    How to explain a regulatory decision

    The reasoning behind a regulatory call is usually sound. The explanation of it, to the colleague who was not in the room when it was made, often is not — and an unexplained decision gets re-argued indefinitely, whether or not it was right.

    Connor Griggs · 7 min read
    A woman points to a hand-drawn dashboard sketch taped to a whiteboard while explaining it to someone off camera
  152. Aug 12026
    Craft

    How to read a regulation, not just the guidance

    Guidance documents are the readable version, so most people learn FDA’s rules from them first. But guidance is a paraphrase of the agency’s current thinking — the regulation is the enforceable text, and reading it directly is a different, learnable skill.

    Connor Griggs · 8 min read
    A student writes in a notebook at a library table, an open laptop and stacked reference books in front of her, bookshelves in the background
  153. Aug 12026
    Careers

    Finding a mentor in regulatory affairs

    There is no residency or licensing exam that hands you regulatory judgment. Almost everyone good at this work learned the parts that matter most from someone who happened to be generous with their reasoning.

    Connor Griggs · 7 min read
    Two women look closely at an open book together at a desk, one pointing at the page while the other listens
  154. Jul 312026
    Craft

    Working with an FDA reviewer during a submission

    The review clock does not stop for good manners, but a submission that moves is usually the one whose answers were anticipated rather than argued with. What actually happens once a submission is in review, and how practitioners work with FDA rather than around it.

    Connor Griggs · 8 min read
    Two people sit at a desk poring over open reference books and handwritten notes beside a laptop, one pointing to a passage on the page
  155. Jul 312026
    Careers

    Writing a regulatory affairs resume from adjacent work

    Almost nobody arrives at regulatory affairs holding a regulatory affairs degree. How to translate quality, clinical, technical-writing, or bench experience into a resume a regulatory hiring manager actually reads — without inventing experience you don’t have.

    Connor Griggs · 8 min read
    A person works at a laptop displaying a document, with an open notebook, pen, and sunglasses on the desk beside them, seen from over their shoulder
  156. Jul 312026
    Careers

    A day in regulatory affairs — what the work looks like

    No two days look alike, and anyone who tells you otherwise is describing a slow week. But the work reliably breaks into the same small set of categories — and it’s worth seeing that shape before you accept an offer, not after.

    Connor Griggs · 7 min read
    A hand writes a numbered list in a spiral notebook beside an open laptop, with colored pencils on a wooden desk
  157. Jul 282026
    Careers

    Teaching yourself regulatory affairs — what actually works

    No employer hands you a curriculum before you have the job. What self-directed study actually looks like when it works, and the two habits that quietly waste a year of it.

    Connor Griggs · 8 min read
    A student works at a laptop beside an open textbook at a library table, rows of bookshelves in the background
  158. Jul 272026
    Careers

    Moving between devices and pharma in regulatory affairs

    The FD&C Act covers both, and a device reviewer and a drug reviewer are trained to ask almost nothing alike. What carries over when you move between the two, and what you have to relearn from zero.

    Connor Griggs · 9 min read
    A person wearing headphones sits at a desk typing on a laptop against a plain wall
  159. Jul 272026
    Craft

    How to read an FDA warning letter

    The observations were never a secret — the company saw them first, at the inspection’s close. What changes at the warning-letter stage, and how practitioners read one for the pattern behind the citations.

    Connor Griggs · 9 min read
    A person at a desk in a dim office reads from a stack of open books while typing on a laptop, a coffee cup nearby
  160. Jul 272026
    Careers

    Is the RAC certification worth it?

    RAPS’ own credential is the closest thing this profession has to a license — and it isn’t one. What the exam actually tests, what a year of study costs you, and who it’s really for.

    Connor Griggs · 8 min read
    Rows of empty tiered seats in a lecture hall, lit by overhead panel lighting
  161. Jul 232026
    Careers

    How to get into regulatory affairs — the honest map

    No degree points straight at this profession, and almost every posting asks for experience you don’t have yet. The routes that actually produce first jobs — and the ones that quietly don’t.

    Connor Griggs · 9 min read
    A student takes notes beside an open laptop while studying at a table
  162. Jul 232026
    Craft

    How to read an FDA guidance document

    Guidance is not law — but reviewers read it as a map of their own expectations. How practitioners take a forty-page PDF apart in an hour, and what they write down.

    Connor Griggs · 7 min read
    Two professionals page through printed documents across a desk
  163. Jul 232026
    Careers

    Your first regulatory interview — what they listen for

    The questions are predictable; the listening is not. What interviewers are actually testing when they ask about a submission you have never run — and how to answer without bluffing.

    Connor Griggs · 8 min read
    A candidate sits across from two interviewers in a bright meeting room

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