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Senior Specialist, Regulatory Affairs

Senior Regulatory Affairs Specialist job is available at a leading global medical device company in the greater Minneapolis area. As the Senior Regulatory Affairs Specialist you will work with a core team focused on New Product Development. The products are within the implantable and surgical tooling space.

You will be responsible for US and EU regulatory submissions. Therefore, experience with authoring 510Ks and design dossiers is required to be in consideration.

It is an exciting time to join a growing company with expanding regulatory and R&D teams.

Responsibilities:

  • Lead author on 510K and design dossier submissions.
  • Work with R&D for design and process changes.
  • Working on international registrations as needed.
  • Manage labelling reviews and changes.
  • Prepare responses to FDA letters, supplements and amendments.

Requirements:

  • Bachelor's Degree
  • Experience writing 510K and design dossier submissions

Salary is depending on experience, range for the senior level goes to up about $105K on the base salary, there is also a bonus associated with the package.

If you are interested and have the regulatory submissions experience, please apply with your resume and Real Staffing will reach out to discuss your experience and opportunity before submitting to the client

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