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Brian Young is Vice President of Regulatory Affairs and Quality Assurance. He is a senior 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.
At Health Policy Associates, Mr. Young works on a wide range of global regulatory, clinical, and quality projects including regulatory strategy, IDE, 510(k), PMA and international submissions, clinical trial development, and quality systems and development.
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.
Mr. 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 extensive experience has led to authored publications in Regulatory Affairs Focus and a textbook chapter on global medical device registration. He has led successful efforts to bring new and highly differentiated products to 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 his Bachelor of Science in Medical Technology from the University of Iowa and his Master’s in Business Administration from Duke University’s Fuqua School of Business.
Mr. Young lives in Boerne, TX with his wife and two children. After years of competitive bike and triathlon racing, he now enjoys recreational swimming and biking. Brian is also a Principal at Parenteau BioConsultants, LLC.