How to Interview a Regulatory Affairs Candidate

Most people who interview a regulatory affairs candidate were never taught how, and default to questions that verify a resume rather than test the thing the job actually requires. “Tell me about your experience with 510(k)s” can be answered just as smoothly by someone who filed one well and someone who watched someone else file one — and it tells you almost nothing about which candidate you’re looking at.

In brief

Resume-verification questions test recall. A stronger interview asks the candidate to reason through a specific, ambiguous scenario close to the actual role, and watches how they work through it.
The clearest signal is usually how a candidate handles disagreement or uncertainty — how they’ve handled being overruled and how they explain a judgment call are close to what the job is actually made of.
Confidentiality limits what a candidate can tell you in specifics. A well-run interview asks about the shape of a decision — the reasoning, the tradeoff, the pushback — rather than demanding names or products a candidate can’t disclose.
What you’re hiring for changes with seniority and headcount — a first regulatory hire needs a different profile than the tenth person joining an established team.

Ask about a decision, not a resume line

Instead of asking whether a candidate has “510(k) experience,” ask them to walk through one specific decision they made on a real submission: a predicate they chose and had to defend, a change they judged significant enough to need a new filing, a claim they pushed back on. Listen for whether they can state the competing considerations plainly, not just the outcome — a candidate who says “I picked this predicate because it matched on intended use and technology, even though a more popular one existed with weaker technological fit” is showing you the actual reasoning. A candidate who can only say “I found a predicate and it got cleared” may still be strong, but the question hasn’t told you that yet, and it’s worth asking a follow-up before assuming it has.

What to watch for in the answer

The strongest signal isn’t the decision itself, it’s what the candidate does when you push on it. Ask what they would have done if the reviewer, or their manager, had disagreed with the call. A candidate who can defend the reasoning, concede a genuinely fair counterpoint, and still explain why they’d hold the position (or why they’d change it) is showing you judgment under real conditions. A candidate who either collapses immediately or refuses to engage with the counterpoint at all is showing you something too — just not the thing their resume claims.

Where this goes wrong

Testing for vocabulary instead of reasoning

A candidate who uses the right acronyms fluently isn’t necessarily the candidate who reasons well under ambiguity — and the interview that only checks vocabulary can’t tell the two apart.

Asking hypotheticals with no real ambiguity in them

A scenario with one obviously correct answer tests whether the candidate can find it, not how they think when the answer genuinely isn’t clear — which is the harder and more common situation on the job.

Not telling the candidate anything true about the role

An interview that only evaluates gives you a one-way read. A candidate deciding whether to accept an offer needs the same honest picture they’d use to evaluate a team before joining — and a candidate who leaves with an accurate picture is less likely to leave again in six months.

Hiring well for this role means testing the same thing the job tests every week: whether someone can reason clearly under real ambiguity and hold their ground, or change it, for a defensible reason. Everything else — the acronyms, the years, the product list — is easier to fake than that is.

Sources & further reading

RAPS — Regulatory Competency Framework raps.org
Regulatory Academy — How to Evaluate a Regulatory Affairs Team Before You Join regulatoryacademy.com
Regulatory Academy — How to Onboard a New Regulatory Affairs Hire regulatoryacademy.com
Regulatory Academy — Handling a Regulatory Decision You Disagree With 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.