Peggy Hansen joined Regenity in October 2001 to head Quality, Regulatory and Clinical Affairs. Peggy has about 30 years of experience in regulatory affairs, clinical research, and quality assurance of implantable medical devices and was appointed General Manager of Regenity’s contract development and manufacturing business in 2020. Before joining Regenity, Peggy was the Manager of Regulatory Affairs at SurModics, Inc., a company specializing in surface modification of medical devices, where she was responsible for the company’s regulatory affairs and quality compliance. Prior to working at SurModics, Peggy was at 3M Health Care, Medical Products Division and Cardiovascular Systems Division where she was responsible for U.S. and global regulatory filings with respect to the company’s class I, II, and III medical devices and combination products. Peggy was also employed by ReGen Biologics, Inc., a company involved in the development of collagen orthopedic products. She is a certified Regulatory Affairs Professional. She received her Bachelor’s degree in Chemical Engineering from Cornell University.
Can help with
- Pitch decks
- Business model ideation
- Product development process, preclinical studies
- Regulatory pathways, submissions and FDA interactions
- Quality management systems and GMP manufacturing