Principal Regulatory Affairs Specialist

Location: Minnesota, USA
Salary: competitive
Job Type: Permanent
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Principal Regulatory Affairs Specialist

Direct hire

Class II devices - 510K authorship

140K + 20% bonus

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

The company designs, develops and manufactures class II medical devices. 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 a new role for the company as they move to a new product development time for the company. It is an ideal time to join, as you will be responsible for authoring multiple 510Ks this year and next and manage the full submission process with the FDA.


  • Leading regulatory strategy for 510K submissions
  • Authoring 510Ks submissions
  • Work in a cross functional capacity with core project teams to manage life cycle from development to commercialisation
  • Manage gap analysis and risk assessments
  • Interact directly with the FDA on submission responses and information requests


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

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

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