Connecting...

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist job opening with a medical device company in the Maple Grove areas of Minneapolis, MN. This is a full time direct hire role.

It is a great time to join the regulatory team as you will be working on getting approval for the first generation of their new product to EU and US market. The first generation is currently undergoing design verification testing. You will work to support clinical trials in the US & EU and manage the clinical trials documentation & data, as well as EU & US submissions as you work through the phases of each product stage. This is a small team so you will have exposure to all regulatory activities for these products.

Future project that are in process are second & third generation of the product where you will support all areas of pre-market regulatory affairs.

This role is part of a new division of a well established global medical device company.

Responsibilities include:

  • Managing EU and US clinical trial regulatory documentations.
  • Write submissions for EU CE marking and US 510K submissions.
  • Support all new product development projects and work cross functionally with R&D for marketing approvals.
  • Support regulatory submission strategy.
  • Regulatory project work as necessary.

Requirements:

  • Bachelors Degree
  • 3 years medical device regulatory affairs experience
  • Insight into clinical and pre-market regulatory affairs for EU and US

Please apply with your resume and Real Staffing will reach out to discuss your application.

Salary goes up to $105K base salary + bonus + benefits

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