Regulatory Affairs Manager
linkedinPrinceton, NJ
Regulatory Affairs Manager
linkedinPrinceton, NJ
13 days ago
Industries
Electromedical and Electrotherapeutic Apparatus ManufacturingSurgical Appliance and Supplies ManufacturingResearch and Development in the Physical, Engineering, and Life SciencesAbout the role
Hiring: Regulatory Affairs Manager | MedTech | NJI'm working with an innovative medical technology company specialising in AI-enabled imaging, surgical navigation, and robotics, looking for a Regulatory Affairs Manager to join their growing team. This is a great opportunity to take ownership of regulatory strategy, lead FDA 510(k) submissions, support clinical studies and hospital collaborations, and work closely with engineering and senior leadership.
What we're looking for:
- 5+ years of medical device regulatory affairs experience
- Strong experience with FDA 510(k) submissions
- Exposure to clinical studies, IRBs, or hospital collaborations
Experience with SaMD, AI/ML, medical imaging, or robotics is a plusNJInterested in learning more, or know someone who might be a good fit? Apply!
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JOB OVERVIEW
Experience level
Manager
Location
Princeton, NJ
Occupation
Regulatory Affairs Managers
Industry
Electromedical and Electrotherapeutic Apparatus Manufacturing
Posted
13 days ago
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