Kay Fuller

IND/IDE Program Manager, University of Michigan Medical School, Ann Arbor, MI

Ms. Fuller manages the Michigan Institute for Clinical and Health Research's IND/IDE Investigator Assistance Program (MIAP). The MICHR MIAP program provides clinical investigators with regulatory support in preparing IND & IDE applications to gain FDA approval to conduct novel drug, biologics and medical device clinical trials. Formerly the Director of Clinical and Regulatory Affairs at Cohera Medical, Ms. Fuller has more than 29 years of industry experience developing and commercializing cardiovascular, neurosurgical, endoscopic, and drug delivery devices. She has successfully led global clinical studies and regulatory marketing authorization submissions for more than 32 Class II and Class III medical devices, via the FDA IDE, 510(k), PMA and EU CE mark processes. Ms. Fuller also spent six years within the OR setting working directly with surgeons from multiple surgical specialties to provide surgical products sales and in-service training. Her distinguished career includes positions of increasing responsibility with global medical device companies, including W. L. Gore & Associates, Pudenz-Schulte Medical (acquired by Medtronic), Circon Endoscopy, C. R. Bard and Terumo. Ms. Fuller earned her undergraduate degree in Veterinary Technology from Texas State Technical College. She is board certified in Medical Device and Pharmaceutical Regulatory Affairs.