Global Regulatory Affairs Principal Leader – Medical Devices
Job in
Norcross, Gwinnett County, Georgia, 30003, USA
Listed on 2026-09-07
Listing for:
Werfen
Full Time
position Listed on 2026-09-07
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Job Description & How to Apply Below
Werfen is seeking a Senior Principal Regulatory Affairs Specialist to support regulatory affairs and quality systems for US, Canada, and EU markets. You will drive submissions (510(k), BLA), maintain technical files, and ensure compliance across global regulatory requirements.
The ideal candidate has 8+ years in medical device regulatory affairs, with strong knowledge of FDA and EU regulations, ISO 13485, and risk management frameworks.
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