Regulatory Affairs Manager Job at Barrington James, Princeton, NJ

  • Barrington James
  • Princeton, NJ

Job Description

Hiring: Regulatory Affairs Manager | MedTech | NJ

I’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 plus

NJ

Interested in learning more, or know someone who might be a good fit? Apply!

Job Tags

Full time

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