Find your next role

Our Open Positions.

Reference: 65 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. 

Apply for this job
Apply for this job

Consultant.

Daniel Spencer
Daniel Spencer
Associate Director  View Profile

Get similar jobs by email.

Create Alert

Apply Now.

If you're interested in this position, please fill out this form with your details and someone will be back in touch with you to discuss this further.

Our locations

We have experts connected around the world.

Global HQ.

Charlton Morris Ltd
34 Boar Lane
Leeds
LS1 5DA

+44113 345 2266 info@charltonmorris.com