Medical Device Regulatory Affairs Specialist

Minneapolis, MN

Industry: Regulatory & Scientific Job Number: 133585

Medical Device Regulatory Affairs Specialist


Background: The client is a large medical device company looking for support on their Regulatory Affairs team. They need a Regulatory Affairs Specialist with a background in Medical Device RA, including 510(k) submissions. This team also deals with International Regulatory Affairs, so this consultant will need to have experience with global registrations, assessing gaps for global product re-classifications, as well as global submissions. Most of the work on this role will revolve around domestic 510(k) submissions but the international experience is also a must to fulfill the role requirements.

Project: The consultant will come onto the team and begin working on 510(k) submissions. Most of the role will revolve around these submissions, so knowledge and experience with 510(k)’ s is a must. Another aspect of the role will involve International Regulatory Affairs, specifically relating to product registrations and assessing need for global re-classification. International RA experience is also a requirement for this role.


Medical Device Regulatory Affairs

510(k) Submissions

International RA

Job Type: Contract 

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