Regulatory Affairs Manager
linkedinPrinceton (NJ)
Regulatory Affairs Manager
Posted 14 days ago
linkedinPrinceton (NJ)
SENIORITY
Manager
About 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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