Senior Regulatory Affairs Manager

Job Summary

A company is looking for a Senior Regulatory Affairs Manager to support North America regulatory activities for in vitro diagnostic devices.

Key Responsibilities

• Prepare and complete technical file submissions for in vitro diagnostic devices
• Develop regulatory strategies and assess product changes for impact on IVD products
• Maintain knowledge of IVD regulations and support global regulatory registrations

Required Qualifications

• Bachelor's Degree in a STEM field with 6+ years of regulatory experience, or a Master's/PhD with 4+ years of experience
• Experience with US 510(k), PMA, and DE NoVo submissions
• Excellent understanding of regulations in the Americas region
• RAC certification preferred
• Ability to work independently and in a matrixed organizational structure