Biology Education

Karen F. Mahoney, Esq. is the Worldwide Vice President, Regulatory Affairs at DePuy Synthes, Johnson & Johnson. Karen leads the DePuy Synthes Regulatory organization with responsibility for driving regulatory strategy and execution for the Orthopedics business worldwide. She has extensive knowledge of the DePuy Synthes business and is a proven leader who has worked at Johnson & Johnson in the DePuy Synthes companies for 25 years, and within the medical device industry for 27 years. Throughout her career, she has had the opportunity to work on all classifications of products in the Spine, Neurovascular, Sports Medicine, Trauma/CMF/Biomaterials, Joints, CMW, Powertools and Digital business units.  Karen has held global roles in Regulatory Affairs, NPD Quality and Compliance. 

Karen is currently on the Board of the Orthopedic Surgical Manufacturers Association (OSMA), is a member of the Advamed Orthopedic Working Group, and a member of the Regulatory Affairs Professionals Society (RAPS).  Karen previously served as a Medical Device Committee Board Member of the Food and Drug Law Institute (FDLI). 

Karen holds a B.S. in Biology from Fairfield University and received her Juris Doctor degree from Roger Williams University, School of Law. She is licensed to practice law in the states of Massachusetts and Rhode Island. Karen will be teaching BIOL 2078, Regulatory Affairs in Pharma, Med Device and Digital Health.