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Regulatory Affairs Project Manager

Regulatory Affairs Project Manager role available for a medical device company in the greater Minneapolis area for direct hire.

As the Regulatory Affairs Project Manager you will be responsible for managing regulatory submissions for the US and international markets. You will work in a cross functional capacity to manage the new product development projects through the submission process. Submissions include 510K, PMA and IDE.

Responsibilities:

  • Liaise with the FDA and various international regulatory agencies through the submission process. Interface on all correspondence and resolve in a timely manner.
  • Plan and manage internal projects for the regulatory department. This includes working with R&D, quality and the greater leadership team to gain regulatory approval of new products.
  • Provide recommendations for regulatory strategy.
  • Lead project meetings internally on a weekly basis.
  • Provide regulatory and compliance support to all members of the project team as needed.
  • Keep up to date on regulatory requirements for US, EU and international agenices.

Qualifications:

  • Bachelor's Degree
  • 4 years of regulatory affairs experience in the Medical Device industry
  • Experience with writing 510K, PMA and IDE submissions
  • 2 years of project management experience for regulatory affairs projects, ideally

This is a direct hire permanent role

Salary is depending on experience level of the candidate

No relocation is available for this opportunity

If you are interested and meet the requirements please apply with your resume and Real Staffing will reach out to discuss the opportunity further

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