Michele Chin-Purcell, PhD | Regulatory Advisor
Dr. Chin-Purcell is a Regulatory Advisor to Neuronoff, Inc.
An experienced compliance, quality and regulatory affairs expert, she is skilled in complex, highly regulated environments, with proven success to negotiate, collaborate, and obtain results with global regulators, within cross-functional teams, across multiple departments and international sites. Michele’s expertise in small and large medical device companies enables her to easily move from hands-on, practical and tactical roles to leadership and strategic roles.
After achieving her PhD in Mechanical Engineering in 1991, Michele began her career in medical devices as a research engineer working at Cardiac Pacemakers, Inc. Over the next 17 years, as the company grew, re-organized into Guidant, and then acquired by Boston Scientific, she enjoyed a career of increasing management responsibility and multiple areas of expertise: Engineering, Regulatory Affairs, Quality Assurance, Global Compliance, and Human Resources. She also completed a several year overseas assignment in Clonmel, Ireland, nurturing the Quality Department in a start-up manufacturing site.
Starting in 2008, Michele branched out to new adventures which included serving as the Executive Director of Research Integrity and Oversight at the University of Minnesota before returning to the medical device industry to focus on roles in Regulatory Affairs and Quality Assurance. From 2010 through 2020, this experience included Senior Director of Regulatory Affairs at St. Jude Medical, and several start-up companies: Senior Director of Regulatory Affairs and Quality Assurance at Corventis, Inc; Senior Director of Regulatory Affairs at Spinal Modulation, leading the effort to obtain US PMA approval of the first neurostimulation device for the Dorsal Root Ganglion for chronic pain; and Vice President of Regulatory Affairs and Quality Assurance at Nalu Medical where she designed the US regulatory strategy for the first commercial release of Nalu’s implantable neurostimulation products. In 2020, Michele focussed on a consulting career, lending her years of expertise to the medical device industry.
Michele received her PhD and MS in Mechanical Engineering from University of Minnesota and a BS in Mechanical Engineering from University of California, Berkeley.