Mac McKeen has more than 30 years of experience in the medical device industry in regulatory and quality roles focused on the development, clinical study and regulatory approvals of cardiovascular devices. He is currently a Fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize. He also serves as an adjunct professor at the University of Minnesota instructing a 4000-level course on medical device development, and is also a Faculty Director within the College of Continuing and Applied Professional Studies. He is actively involved in advocacy and collaboration with the FDA through industry associations including AdvaMed, MDIC, MDMA, Medical Alley and RAPS. Mac is RAC certified and elected as a Fellow at the Regulatory Affairs Professional Society (F.R.A.P.S).