Deb Sheffield
Chief Regulatory Officer
Deborah Sheffield is Chief Regulatory Officer at Galvanize. She is an experienced professional in the design and development of innovative products, with over 25 years of experience in and understanding of the global regulatory environment in the medical device field. She has successfully obtained US and International medical device approvals for clinical studies and market clearance/approvals for Class I, II and III devices in markets including US, Canada, Australia, South America, India and Europe. Her technology experience encompasses a variety of medical devices platforms, including energy-based therapies (RF, laser, ultrasound, IRE), active implantables, and IVD devices for disease states including neuro, pulmonary, GI and cardiac functions.
Deb has previously held several key leadership positions at companies including Johnson & Johnson and at several start-up companies including Northstar Neuroscience (IPO and subsequently acquired by St. Jude Medical). She holds a BS from Kettering University in Industrial Manufacturing Engineering and a MS from Oakland University in Applied Statistics. She also attended the University of Cincinnati Nursing School with a focus on clinical research.