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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 Specialist - REMOTE
Under minimal supervision: Provide independent regulatory guidance to product development teams in strategic planning, pre-marketing, and related submissions to support optimal timelines for new/modified product launches, including submissions to transition devices from MDD to MDR compliance. He/she guides conformance with applicable regulations in product development, support of claims, content labeling, and promotional materials and helps to define data and information needed for regulatory approvals in conjunction with cross-functional product development teams.
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