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Principal Regulatory Affairs Specialist

Principal Regulatory Affairs Specialist opening for permanent direct hire opportunity with a medical device company in Eden Prairie, MN.

As the Principal Regulatory Affairs Specialist you will be working on critical design development projects, where you will be advising on regulatory strategy and build the regulatory processes in order to author and submit 510K submissions.

The company designs, develops and manufactures class II medical devices, which are personal electronic devices with wireless components. They have commercial products on the market now and you will also be working on new designs and next generation products which have new features, technologies and applications.

It is an exciting time to join the company, so you will be responsible for authoring multiple 510Ksthis year and next and manage the full submission process with the FDA. There is also global markets including EU technical file submission activities.

Requirements:

  • 5-10 years regulatory affairs experience with medical devices, to include 510K authorship.
  • Experience work with quality management systems.
  • Bachelors Degree in engineering or scientific field

Salary is up to $130K base with 20% bonus

There is the option to work from home at least 1 day per week

If you are interested please apply with your resume and Real Staffing will reach out to discuss

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