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Senior Manager, Regulatory Affairs


We are currently looking to add a Senior Manager of Regulatory Affairs for a large Medical Device company in the Northern Chicago Suburbs. The Senior Manager of Regulatory Affairs will report to the Senior Director of Regulatory Affairs. This person will have four direct reports.

The Senior Manager will be responsible for formulating a Regulatory Strategy for a Class II Medical Device product line. This strategy will drive all of the U.S. and Global Submissions. This person must have strong leadership and managerial skills as well as a strong technical background. They will be a mentor and guide their team to successfully bring products to market.

This company has a wide variety of Medical Devices and a robust pipeline. This person will gain a great breadth of experience from a global company.
Education:

  • 4 Year Bachelor's Degree, Life Sciences Preferred
  • RAPS/RAC Certified or Higher Degree is a plus

Requirements/Responsibilities:

  • 6+ Years of Regulatory Affairs Experience in Medical Device Industry
  • 2+ Years of People Management in RA
  • Author of 510(k) and CE Mark submissions
  • Successful Track Record of creating Regulatory Strategy
  • Electromechanical Device experience is a plus
  • Ability to lead and teach a team

If you are interested please send your resume to Brandon Johnson at Real Staffing. This role is an immediate need and is a Direct-Hire Permanent position.

Sthree US is acting as an Employment Agency in relation to this vacancy.