Connecting...

Regulatory Affairs Project Manager

  • Job type Permanent
  • Salary US$100000 - US$111000 per annum + competitive
  • Location Edina, Minnesota
  • Sector Regulatory Affairs (RA)

A global Medical Device company specialising in IVD products based in Edina Minnesota is hiring for a Project Manager of Regulatory Affairs to join their pre-market team.

As Project Manager of the Regulatory Affairs group this person will world cross functionally with a team of 9 individuals and will be responsible for the authorship of a number of 510(k) clearances.

This person will get direct FDA exposure and will be involved in negotiations with the FDA on behalf of this client.

Required experience:

  • Bachelor's Degree in Regulatory, Chemistry, Biology, or other technical field.
  • 5-7 year's experience in regulatory affairs in Class II and III products, preferably with laboratory and Point of Care IVD instruments and reagents and/or blood glucose monitoring devices.
  • Experience handling medical device regulatory submissions related to infectious diseases is preferred.
  • Experience of direct relationship and involvement dealing with FDA related to submissions, preparation and follow up.
  • Proven proactive project management, team-based skills.

This is an exciting opportunity with a medium sized Medical Device firm, the culture is supportive and collaborative.

The product pipeline is extremely robust meaning the opportunity to author 510(k)s and lead regulatory projects is ample.

Interviews are commencing in early September, please send an up to date resume to Mary Joyce to be considered for this position.

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