The Regulatory Academy Blog

Office Hours

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 Craft “Looks good” is not a review. What to actually check before you sign off on someone else’s draft. Connor Griggs · 5 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.

83 essays

  1. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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
  9. 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
  10. 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
  11. 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
  12. 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
  13. 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
  14. 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
  15. 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
  16. 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
  17. 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
  18. 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
  19. 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
  20. 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
  21. 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
  22. 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
  23. 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
  24. 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
  25. 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
  26. 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
  27. 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
  28. 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
  29. 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
  30. 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
  31. 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
  32. 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
  33. 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
  34. 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
  35. 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
  36. 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
  37. 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
  38. 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
  39. 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
  40. 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
  41. 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
  42. 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
  43. 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
  44. 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
  45. 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
  46. 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
  47. 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
  48. 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
  49. 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
  50. 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
  51. 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
  52. 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
  53. 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
  54. 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
  55. 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
  56. 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
  57. 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
  58. 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
  59. 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
  60. 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
  61. 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
  62. 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
  63. 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
  64. 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
  65. 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
  66. 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
  67. 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
  68. 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
  69. 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
  70. 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
  71. 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
  72. 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
  73. 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
  74. 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
  75. 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
  76. 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
  77. 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
  78. 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
  79. 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
  80. 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
  81. 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
  82. 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
  83. 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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Office Hours answers the questions around the work. The courses teach the work itself — free, practitioner-written, and structured so each lesson builds on the last. Start with the 510(k).

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