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Director of Regulatory Affairs

We are currently looking to hire a Director of Regulatory Affairs for a Class II Medical Device company. This is a Direct-Hire Permanent position that is immediately available. The company is a Small to Medium size medical device company that has seen exponential growth. The company has an excellent culture and everyone acts as a family.

The Director of Regulatory Affairs will report to the Vice President of RA/QA. The main responsibilities of the Director of Regulatory Affairs will be to create a Regulatory Strategy for the full life-cycle of the company's products. This person will directly communicate with the stakeholders and be responsible for leading the Regulatory Affairs team.

This is a global role and this person will be the main point of contact for all submissions and audits. This person will directly negotiate with the Regulatory Agencies for 510(k)'s, CE Mark, and other Regulatory documents. This person will be responsible for leading cross-functional groups on new product development and post-market activities.

The Salary Range for this Position is $175,000 - $200,000 plus Bonus and Comprehensive Benefits

Please read the following requirements:

Education:

  • Bachelor's Degree in the Life Sciences
  • Master's or Ph.D. Preferred
  • RAC is a plus

Experience/Expectations:

  • 10+ Years of Regulatory Affairs in the Medical Device Industry
  • 3+ Years of managing direct reports
  • Proven history of creating a successful Regulatory Strategy
  • Directly communicated with Regulatory Agencies
  • Author of Multiple 510(k)'s and International Submissions
  • Familiar with changing regulations such as MDR 2020
  • Full Life-Cycle Management experience

If you are interested please send your updated resume and availability for a phone call to Brandon Johnson at Real Staffing. Interviews will start in 2 weeks.

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