Senior Manager Regulatory Affairs

We’re partnered with a mid-size Class II Medical Device business looking for a Senior Regulatory Affairs Manager. This is a fantastic opportunity to join a busy, energetic team with scope to grow and shape the direction of the RA function.

The company are aiming to complete 510(k) for their device in 2027 and have new products in the pipeline for 2027 and beyond.

• Full time Permanent Opportunity
• Start Date:
  
  August/September 2026
• Location:
  
  Hybrid with some travel to Minneapolis, MN
• Competitive Salary + Bonus + Benefits
• US-Based candidates with right to work only

• Leading the business’ US Regulatory Affairs operations, including submissions to FDA
• Managing, hiring, training and developing a small but growing RA team (currently
  4)
• Liasing with Internal, Partner, and Regulatory stakeholders
• Writing, reviewing, and compiling regulatory documentation
• Ensuring compliance with Class II device regulatory requirements
• Working cross-functionally with R&D and Quality on strategic projects including New Product Development and Submissions

• 8+ years of Regulatory Affairs experience in Medical Devices, ideally with Class II experience
• Strong knowledge of RA processes across US markets (510(k), PMA, IDE etc.
• High attention to detail, excellent organisation, and ability to manage multiple priorities
• Previous Management of RA teams