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Back to search resultsRegulatory Affairs Manager
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![]() United States, Minnesota, Eden Prairie | |||
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Regulatory Affairs Manager Department
Diagnostics - Grason-Stadler Job Locations
US-MN-Eden Prairie
Overview The Regulatory Affairs Manager is responsible for leading regulatory functions and serves as management representative. Responsibilities include ensuring compliance with medical device standards and regulations, which include: 21 CFR Part 820 Quality system Regulation (QSR), ISO 13485, Regulation (EU) 2017/745 (MDR), and SOR/98-282 Canadian Medical Device Regulations (CMDR). In addition, they will support Manufacturing and Engineering functions in all phases of design, development, production, and distribution of medical devices. Responsibilities Supervisory Responsibilities:
Recruit, interview, and hire new employees.
Duties/Responsibilities:
Qualifications
Education and Experience:
Travel:
Physical Requirements:
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