Kenneth (Ken) Kleinhenz, MS, MBA
Chief Regulatory Officer

Biotechnology trailblazer Kenneth Kleinhenz, MS, MBA, has driven several industry “firsts” that have since become standard medical practices nationwide — garnering 25-plus FDA clearances along the way. As Chief Regulatory Officer at University Medical Devices, his three decades of quality assurance experience keeps company policies and procedures in line with ever-evolving governmental policies.

Ken’s keen eye for medical device compliance ensures all products meet and exceed legal expectations among diverse patient user bases while upholding FDA Human Practice Engineering guidelines from end to end.

Ken has led the industry to several groundbreaking innovations — including the first bioresorbable spinal plate and screw system 510(k) cleared by the FDA; the first bioresorbable cranial-facial distraction system 510(k) cleared by the FDA; and the first bioresorbable spinal interbody device CE Marked in the European Union.

Prior to joining the University Medical Devices team, Ken held numerous, executive-level quality assurance and regulatory affairs positions at public and private biotechnology companies. Namely, he served as Vice President of Global Regulatory Affairs at Cytori Therapeutics for more than 18 years.

Before that, Ken was Vice President of Quality and Regulatory at Avelas Biosciences; Director of Regulatory Affairs at MacroPore Biosurgery; Chief Microbiologist for Becton Dickinson; and Manager of Quality Assurance and Regulatory Affairs at Pacific Pharmaceuticals, where he successfully negotiated a Pre-Market Approval (PMA) for a novel dental diagnostic for periodontal disease.

A highly sought-after speaker for the FDA’s Medical Device Manufacturers Association, Ken frequently provides thought leadership on a range of regulatory affairs topics. On top of his dozens of FDA clearances, his work has earned 10-plus European Union CE Marks and 25-plus other international approvals for bioresorbable products in Asia and Australia.

Adding to Ken’s impressive career track record, he’s also a veteran of the U.S. Navy — where he served as a Clinical Microbiologist for six years at the San Diego Naval Hospital. He received his BA in microbiology at the University of California, San Diego (UCSD) and his MBA at the University of Phoenix.