James Lorkowski

James Lorkowski is a seasoned professional in the field of regulatory affairs with extensive experience in the medical device and combination product sectors. Currently serving as Sr. Director of Global Regulatory Affairs Devices & Combination Products at Takeda, James has held significant positions at leading companies including Merck, where responsibilities included Director of Device and Drug Device Combination CMC Regulatory and Associate Principal Scientist in Regulatory Affairs. James also served as Director of Regulatory and Clinical Affairs at Topcon Medical Systems and has a strong regulatory background from roles at GE Healthcare and STERIS Corporation, where engineering and international registrations were primary focuses.