FDA Regulatory Affairs Consultant: Submissions & QMS Expert

Posted today

stevenson search partnersMillbrae (CA)

Regulatory Affairs Specialists Electromedical and Electrotherapeutic Apparatus Manufacturing

SENIORITY

Senior

Apply

About the role

Stevenson Search Partners partners with a global medical device company to fill a Regulatory Affairs Consultant role in San Francisco, focusing on FDA submissions and pre-submission activities. The ideal candidate has 5+ years in regulatory affairs, deep FDA knowledge (21 CFR 807; 803/806/820 a plus), and hands-on experience with software/AI submissions to FDA. Collaboration with R&D, QA, and Clinical Affairs is essential.

Before you apply

Applying takes about a minute. These four things decide how fast it moves after that.

Your profile is current

It's what we read first. Occupations, seniority and locations matter more than a long history.

Two examples you can talk through

Not a portfolio — just two pieces of work where you can explain the decisions and what you'd change.

A number in mind

What you're on now and what would make you move. We negotiate better when we know both.

Your notice period

Employers plan around it, and it's the question that stalls offers most often.

Once you apply, someone reads it and calls you before anything reaches the employer — usually within two working days.