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Reference: 66 13/10/2021 08:10:10

Director Regulatory Affairs.

Dallas Fort Worth Area Base, Bonus, Stock, Health, Dental, 401K

A fantastic opportunity to lead Regulatory strategy for a high value, market leading business segment. Role focus includes creating Regulatory strategy for acquired products whilst expanding US based devices into global markets.

The Company

A manufacturer of Class II & III devices for Orthopedic & Spine surgery. The organisation are around $500m, with a business strategy to double in size in the immediate future. Engaged in M&A's, investing significantly in new talent & product development, it's hard to find a company that offer such a unique career prospect with fantastic professional development capabilities.

The Role

The Director of Regulatory Affairs is a key partner with Research & Development, Regulatory and commercial teams for all aspects of new product development and commercialization. You will lead the global Regulatory program for a US market leading business, with huge growth potential in international markets. 

All aspects of expertise will be required for 510(k) & PMA submissions, regulatory compliance and international operations. Partnering with the FDA & international Regulatry bodies, you will drive a team focused on driving high quality RA work, that can deliver exceptional products to patients worldwide. 

Experience Required:

  • 8+ years' medical device Regulatory Affairs experience
  • Proven success in a Regulatory leadership position. (Senior Managers & Manager's will be considered)
  • Experience working with Electronic & implantable medical devices is advantageous
  • A background in engineering and/or a strong technical engineering understanding.
  • Proven track record of strategizing international registration & submission activities with the FDA & global bodies.

The position reports into the global Senior Vice Presodent of RA/QA. You will need to reside in Texas, with full relocation support offered. 

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Daniel Spencer
Daniel Spencer
Associate Director  View Profile

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