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US FOOD AND DRUG ADMINISTRATION, OFFICE OF REGULATORY AFFAIRS
United States - Nationwide
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University of Texas Medical Branch at Galveston
Galveston, Texas
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Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois
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Quality & Regulatory Director
Ensure D. A. Surgical is compliant with applicable global regulatory requirements, and that regulatory requirements are properly translated into company procedures and practice. Expansion and implementation of Quality Management Systems for D. A. Surgical (a Class I Medical Device company). Responsible for all quality systems within the company and enforcement of quality system requirements for suppliers/vendors. Prepares trending reports for quality process execution for the company (both internal and external sources). Responsible for non-conformance resolutions (product and process) and CAPA executions. Directs, through management team and staff, compliance to Quality Management System and Medical Device Regulations. Essential Duties and Responsibilities
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