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Regulatory Affairs Specialist

Company: GForce Life Sciences
Location: Saint Paul
Posted on: May 12, 2022

Job Description:

Job Title : Regulatory Affairs Specialist
Location : St. Paul, MN
Duration : 12+ Months

Help with our international regulatory team to decipher product skus that can be released to different geography (product release authorization process)
--- Need to have some understanding of global medical device regulations
--- Good at data crunching, cross-referencing different database to provide evidence of proof of particular geography product release
--- Be a liaison between our EP International Reg Ops group, and Shared Service Reg Ops and our BU RA submission team to sort through discrepancies on product skus and make sure we confirm correct ones should be released to particular geography
--- Manage and assist countries submission documents that leverage CE mark approval

Skills:
Have working knowledge in EU MDR
Have working knowledge in Regulatory Change Assessment in
Have working knowledge in US and EU medical device submissions
Have experience supporting internal and external inspections
Work cross-functionally and in a matrixed environment
Have experience with continuous improvement activities

Keywords: GForce Life Sciences, St. Paul , Regulatory Affairs Specialist, Other , Saint Paul, Minnesota

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