Most of what makes someone good at regulatory affairs doesn’t announce itself — a question resolved quietly, a delay prevented, a risk flagged before anyone else saw it. If you want credit for it at review time, you have to be the one who wrote it down.
Write it down before you need it
A decision log built for exactly this reason — a running note of what you decided and why, kept as you go — is the same habit that makes a performance review easy to write. The entries that matter aren’t “worked on the Q3 submission”; they’re specific: the labeling gap you caught before it reached the reviewer, the predicate you talked the team out of using and why, the week you shaved off a review by resolving a flagged item early. None of that survives a year in memory as clearly as it survives in a note written the day it happened.
This isn’t about logging everything. It’s about logging the handful of moments each quarter where your judgment, not just your effort, changed the outcome. Those are the entries a review actually needs.
Translate the work for someone who doesn’t do it
Your manager may not read 510(k)s, and even a manager who came up through RA won’t have watched the file the way you did. “Responded to an additional information request” is a task; “kept the review on schedule by resolving three flagged items inside the response window” is an outcome someone outside the function can actually evaluate. The translation step is yours to do — nobody else knows which technical moves mattered enough to be worth naming.
This gets easier over time, and it’s part of what a review is actually measuring: whether you’re starting to think about the work the way the next level up does. Understanding what that level actually rewards before the conversation happens is worth more than any single accomplishment on the list.
Where this goes wrong
Waiting until review week to remember what you did
A year compressed into a few days of memory reliably loses the moments that mattered most and keeps whatever happened most recently.
Listing tasks instead of decisions
“Reviewed submissions” tells a manager nothing; “caught a labeling gap that would have added weeks to review” tells them exactly what your judgment was worth.
Not asking in advance what the review actually measures
Walking in without knowing what “meets expectations” means for your specific role leaves you defending a case built for the wrong rubric.
A performance review rewards documentation nearly as much as it rewards the work itself. Keep the record as you go, translate it for the room you’re in, and the review stops being a scramble and starts being a formality.
Sources & further reading
- Regulatory Academy — The Case for a Regulatory Decision Log regulatoryacademy.com
- Regulatory Academy — Moving from Individual Contributor to RA Manager regulatoryacademy.com
- Regulatory Academy — The Regulatory Affairs Career Ladder, Explained regulatoryacademy.com
This essay is provided for general educational purposes and reflects the regulatory landscape as of its publication date. It is not legal, regulatory, or career advice.
