Leadership, Regulatory Affairs, Clinical Research, Medical Device Product Development
Kristy Simmons is an Engineering Program Director in the Cardiac Rhythm Disease Management Group at Medtronic. She leads a cross functional team in the product development activities for life saving medical technology.
Ms. Simmons spent 12 years in the Clinical Research and Regulatory Affairs Organizations at Medtronic where she was responsible for the leadership of multiple clinical programs and the strategic implementation of regulatory activities to ensure compliance and timely global commercialization of products.
Ms. Simmons is proficient in all U.S. submission types; including Original PMA, PMA-S, 510(k), IDE, Advisory Panels, post market surveillance, and post-approval submissions. Ms. Simmons has experience with combination products and pharma GMPs. She has international regulatory expertise in the European Union, Japan, Canada, and Australia.
Before joining Medtronic, Ms. Simmons held positions in the areas of Sales, Quality Systems, and Regulatory Affairs at Empi Medical and MinRad / BioVector.
Education and Professional Affiliations
B.S., Biology - Saint Norbert College M.S., Manufacturing Systems - University of Saint Thomas Regulatory Affairs Certification (RAC).