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US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
United States - Nationwide
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois
Fred Hutchinson Cancer Center
Multiple Locations, Washington
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Senior Regulatory Affairs Specialist
The Senior Regulatory Affairs Specialist has a supporting role in the planning, coordination, and execution of Hycor’s global regulatory submissions. She/he must have excellent organizational skills, excellent verbal and written communication skills, have the ability to motivate and support teams and have in vitro diagnostic (IVD) technical skills and/or regulatory affairs operational skills. The Senior Regulatory Affairs Specialist must have knowledge of applicable regulations and guidelines. The Senior Regulatory Affairs Specialist, through individual contribution will: Write and prepare regulatory submissions and filings required for U.S. FDA and other international authorities (Pre-Sub, 510(k), CE technical documentation, MDR, Vigilance Reports, etc.)
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