Medical Device Regulatory Affairs Specialist (Partially Remote)

Detroit, MI

Job ID: 123896 Industry: Med

Medical Device Regulatory Affairs Specialist (Partially Remote)

Project Description:

Our client is a large global leader in oral healthcare products. They develop and manufacture a number of Class I & II oral Medical Devices, OTC Pharmaceuticals and Cosmetic products.   They are currently in need of a Regulatory Affairs Specialist to provide day-to-day support for their Regulatory Affairs team. 

Responsibilities:

This individual will have a background in Regulatory Affairs for the Medical Device and Pharmaceutical industries. Our client’ s products are 70% Class I & II Medical Devices, and 30% OTC Pharmaceutical products. For this reason, job duties will be primarily focused in the Medical Device space, but the client seeks a candidate with both Medical Device & Pharmaceutical (OTC) experience. This individual will be responsible for supporting the client’ s Regulatory Affairs group, providing Domestic and International Product Registrations support. The primary regions will include the US, EU and Canada, so therefore this individual should have knowledge/experience with US FDA, EU CE Mark, and Health Canada from a Regulatory Affairs standpoint. The Regulatory Affairs Specialist will also be responsible for Labeling Review. This individual may be tasked with some 510(k) writing/review, but based on the client’ s products they do not foresee needing much support from a Regulatory Submissions standpoint.

The client uses Alcohol in some of their manufacturing processes, so any experience dealing with county authorities for Alcohol/Ethanol Registrations would be a plus.

 

 Required Skills:
  • Medical Device (Class I & II): 3-5 years
  • Pharmaceuticals (OTC): 3-5 years
  • Regulatory Affairs: 3-5 years
  • Domestic & International Registrations: 3-5 years
    • US FDA, EU CE Mark, Health Canada
  • Labeling Review: 3-5 years

Plus:
  • Oral Products
  • Alcohol/Ethanol Registrations

Job Type: Contract 

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