Primary Job Title VP of Vitro Diagnostics Regulatory & Quality Primary Organization Precision for Medicine
Location Bethesda, Maryland, United States Regions Washington DC Metro Area, East Coast, Southern US Gender Female
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Judi Smith is the Vice President, In Vitro Diagnostics Regulatory and Quality at Precision for Medicine. She has worked in the medical products regulatory submissions and approvals, quality, and clinical trial areas for over 30 years. In her role, she oversees the group responsible for the full range of in vitro diagnostic and blood screening
assays (IVDs) services. These include regulatory strategy, analytical and clinical study designs, protocol development, all FDA pre-market and post-market submissions, quality system establishment and auditing per FDA Quality System Regulation, and clinical laboratory set-up per Clinical Laboratory Improvement Act (CLIA) regulations. In addition, the group provides development and management of clinical trials for these products, the data from which are used in regulatory submissions.
In addition, Judi is a member of the FDA/Industry Roundtable and was awarded the FDA Group Recognition Award. She has served as President of the Association of Medical Diagnostics Manufacturers since 2006. This organization is dedicated to the IVD industry and provides educational programs with FDA’s Center for Devices and Radiological Health Office of In Vitro Diagnostics and Radiological Health. Ms. Smith is also a faculty member of the Regulatory Affairs Professional Society (RAPS) University and serves as a Board Member of RAPS.
Judi received her Bachelor of Science from Temple University and her Master of Science from the Medical College of Pennsylvania.
