Kay Fuller, RAC
Ms. Fuller is president of MDRS, LLC, a regulatory consulting firm that specializes in providing strategic FDA and global regulatory, product development and clinical research expertise to biotechnology companies throughout the translational “bench-to-bedside” product life cycle. She has more than 40 years’ experience developing, validating and commercializing complex medical device, biologic and combination drug/device products, as a board certified regulatory affairs professional.
Ms. Fuller has led successful global clinical studies and regulatory marketing authorization submissions for more than 40 Class II & Class III medical devices and combination products, via the FDA IDE, IND, 510(k), PMA and EU CE mark processes, which have enabled over $5B in global medical product sales.
In addition to her regulatory, clinical research and product development experience, Ms. Fuller previously served as an inaugural member of the UM-BME Coulter Translational Partnership Program Technical Oversight Committee and as the initial Core Leader of the National Standards and Compliance Advisory Core for the NIH National Cancer Institute’s Network for Translational Research (NTR): Optical Imaging in Multimodal Platforms program.
A seasoned regulatory executive, strategist, speaker, and author, Ms. Fuller has guided many organizations toward gaining FDA enforcement action resolutions, including those associated with warning letters and product recalls. She also consulted for two of the largest FDA federal court ordered consent decrees (Pharmaceutical and Biologics Manufacturers) as a nationally recognized third-party cGxP regulatory and quality systems management expert.
Ms. Fuller has held R&D, regulatory and clinical affairs management positions with global medical device companies, including W. L. Gore & Associates, P-S Medical (acquired by Medtronic), Bard, Terumo Corporation, Tangent Medical and Rindex Medical. She is the primary inventor on three patents and received her undergraduate degree in Veterinary Technology from Texas State Technical College.