Brian Young

Brian Young is a regulatory, quality, and clinical professional with 30 years of diversified work experience in the medical device and diagnostic industry. He is the former Vice President of Global Regulatory and Clinical Affairs at Kinetic Concepts, Inc. His experience includes a broad range of clinical and therapeutic areas including orthopedics, wound care, aesthetic products, in vitro diagnostics, general surgery, and cardiovascular surgery. Young brings a vast amount of FDA experience including significant face-to-face experiences with the agency. He has filed numerous global submissions for Class II and Class III devices, led federal, state and international compliance inspections, and developed quality systems from the ground up. His experience has led to authored publications in Regulatory Affairs Focus and a textbook chapter on regulatory strategy in Global Medical Device Registration. Young has led successful efforts to bring new and highly differentiated products to the US, Canada, Europe, India, China, Japan, and Brazil. His international experience includes obtaining the first approval for a new technology category in Japan and a first foreign approval for a new technology category in China. He received a Bachelor of Science degree in Medical Technology from the University of Iowa and a Master of Business Administration degree from Duke University’s Fuqua School of Business.