Mac McKeen has 35 years of experience in the medical device industry in regulatory and quality roles focused on the Total Product Life Cycle related to the product development, quality compliance, clinical study, and the regulatory submission and approval of cardiovascular devices. Recently retired Mac served as a Fellow at Boston Scientific with previous leadership roles at Guidant, Medtronic, St. Jude Medical, Cardiac Science and Phillips Medisize.
In these roles Mac has prepared and submitted well over 500 submissions to FDA and global regulatory agencies. For the last 17 years Mac has served as an Adjunct Professor at the University of Minnesota instructing undergraduate and graduate level courses in the Technological Leadership Institute on medical device development.
Throughout his career Mac has been and continues to be actively engaged in a wide range of industry and patient advocacy initiatives working directly with FDA, AdvaMed, RAPS, Medical Alley, MDIC, and the Smithsonian Institute. Mac holds a BS in Industrial Technology from Iowa State University and an MBA from the University of Dallas and is RAC certified and has been recognized as a Fellow by the Regulatory Affairs Professional Society (F.R.A.P.S) and is currently serving on the RAPS RAC Examination Board.