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Senior Regulatory Affairs Specialist - SaMD & FDA ; k
Job in
Irvine, Orange County, California, 92713, USA
Listed on 2026-01-22
Listing for:
BioTalent
Full Time
position Listed on 2026-01-22
Job specializations:
-
Healthcare
Medical Science Liaison, Healthcare Compliance
Job Description & How to Apply Below
A growing medical device company seeks a Senior Regulatory Affairs Specialist in California. This hands-on role involves supporting FDA 510(k) submissions for Class II devices and collaborating with cross-functional teams. Ideal candidates will have over 5 years of experience in medical device regulatory affairs and be familiar with regulatory compliance for promotional materials. You'll play a crucial part in ensuring impactful patient-facing technology while enjoying competitive compensation and flexible PTO.
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Position Requirements
10+ Years
work experience
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