Regulatory Affairs Manager

Hiring: Regulatory Affairs Manager | MedTech | NJ

Read the overview of this opportunity to understand what skills, including and relevant soft skills and software package proficiencies, are required.
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. xzbcwsv
What we're looking for:
5+ years of medical device regulatory affairs experienceStrong experience with FDA 510(k) submissionsExposure to clinical studies, IRBs, or hospital collaborationsExperience with SaMD, AI/ML, medical imaging, or robotics is a plus
NJInterested in learning more, or know someone who might be a good fit? Apply!