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Senior Regulatory Affairs Lead, Class III Medical Devices
Job in
Somerville, Middlesex County, Massachusetts, 02145, USA
Listed on 2026-08-11
Listing for:
BioTalent
Full Time
position Listed on 2026-08-11
Job specializations:
-
Science
Healthcare Compliance
Job Description & How to Apply Below
Bio Talent in Massachusetts is seeking a Senior Regulatory Affairs Specialist to lead and execute regulatory strategies for complex Class III medical devices, collaborating with Clinical, Quality, R&D and Manufacturing teams in a fast-paced, growth-oriented environment.
The role centers on leading FDA submissions (including PMAs), global registrations, and guiding design controls, risk management, and product commercialization throughout development.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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