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Regulatory Affairs Senior Director - medical device

  • Permanent
  • US$99000 - US$210000 per annum + bonus, relocation compensation, benefits
  • Minneapolis, Minnesota
  • Regulatory Affairs (RA)

Regulatory Affair Senior Director role available for a Medical Device company in the greater Minneapolis area, MN.

As the Regulatory Affairs Senior Director you will be responsible for regulatory strategy globally. You will lead a local and remote regulatory team to provide regulatory leadership as well mentoring and performance development planning.

You will partner with R&D, marketing, clinical, quality and various other departments to ensure regulatory compliance. It is an exciting time to join the company as you will be working on new products as well as new generations of current marketed products on a global basis.

As the Regulatory Affairs Senior Director you will be the primary point of contact for the FDA and as well as international regulatory agencies.

Responsibilities:

  • Lead preparation of global submissions including 510Ks, IDE, PMA, CE markings as well as any follow up and responses.
  • Provide leadership to the company for global regulatory strategy.
  • Manage relationship with FDA and other global regulatory agencies.
  • Collaborate cross functionally with clinical, R&D, marketing, quality etc for all regulatory processes.
  • Keep on top of all global regulatory compliance changes and input into the company as required.
  • Foster a collaborative culture and team player mentality.

Requirements:

  • Bachelor's Degree in engineering or science.
  • 12 years of experience with medical device regulatory affairs.
  • People management experience, ideally have experience managing local and remote based teams.
  • Experience with regulatory submissions for complex products ideally with software and hardware components including 510K, IDE, PMA and/or CE markings.
  • Ability to develop and deploy a regulatory strategy on a global basis.

This is a permanent direct hire role.
Salary is depending on candidates experience and also includes a very competitive bonus structure.
If you are not living locally in Minneapolis, there would assistance available for relocation compensation.

*******If you are interested in this opportunity please apply with your resume and Real Staffing will reach out to discuss your application prior to submitting to the client

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