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US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
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University of Texas Medical Branch at Galveston
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Ann & Robert H. Lurie Children's Hospital of Chicago
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Fred Hutchinson Cancer Center
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Senior Regulatory Affairs Specialist
Job Summary: The Sr. RA Specialist provides support for the regulatory department to ensure efficient and compliant business processes and environment. Partner across business functions assisting in identifying data needed, obtaining required documentation, and ensuring that submissions are effectively presented for product registrations. Essential Functions & Accountabilities: Leads the preparation and submission for regulatory approvals and acts independently to identify and resolve problems. Review and approve device labeling and marketing materials for compliance with applicable regulations. Negotiate with regulatory authorities to resolve questions/issues that arise during the product lifecycle.
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