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Senior Regulatory Affairs Lead - Class III PMA Submissions
Job in
Los Gatos, Santa Clara County, California, 95032, USA
Listed on 2026-09-04
Listing for:
Shifamed
Full Time
position Listed on 2026-09-04
Job specializations:
-
Science
Healthcare Compliance
Job Description & How to Apply Below
Shifamed is seeking a Principal Regulatory Affairs Specialist in Los Gatos, CA to lead US, EU, and Japan regulatory activities for a class III mechanical circulatory support device. The role focuses on submission strategy, planning, and writing with Supira Medical team and consultants.
Responsibilities include writing major submissions (IDE, PMA, EU Design Dossiers, Shonin), coordinating priorities, guiding team, and ensuring regulatory compliance; hybrid work, competitive salary, equity.
#J-18808-LjbffrPosition Requirements
10+ Years
work experience
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