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  1. Office of Regulatory Affairs

Jan Welch, Director, Office of Medical Device and Radiological Health Operations

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 Jan Welch

Jan Welch serves as director of the Office of Medical Device and Radiological Health Operations, within the Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA).  Ms. Welch leads organizational change to a commodity-based program emphasizing specialization and vertical integration of regulatory processes. 

Ms. Welch previously led the Office of Compliance in FDA’s Center for Devices and Radiological Health, overseeing the assessment and enhancement of medical device quality through broad-based FDA change initiatives and daily operations. She was also a quality system expert providing expert opinion on medical device legal cases; developing and presenting extensive training on the quality system regulations, and representing FDA and the U.S. in several international guidance and standards activities.

Previously Ms. Welch worked at the Office of Compliance in the Center for Biologics Evaluation and Research. Before joining FDA, she worked for the American Red Cross, the National Institutes of Health,, and Vanderbilt University Medical Center. 

Ms. Welch holds a Bachelor of Science in biology from Wake Forest University in Winston-Salem, NC, and a Master of Health Science in immunohematology from the Medical University of South Carolina in Charleston, SC.