Robert O’Holla joined Endeavour Vision as a Senior Advisor with a focus on regulatory matters. Bob has over 37 years’ experience in the health products market.
Previously Bob was Worldwide Vice President of Regulatory Affairs for the Medical Devices and Diagnostics Group at Johnson & Johnson before retiring from the company in May 2008. Through his career, Bob has held both regulatory, R&D, and quality assurance positions with manufacturers of medical equipment, implants, and sterile disposables. He has managed sterilization laboratories, R&D IT functions, as well as Information Sciences, Regulatory Affairs, and Compliance Groups.
Bob has extensive experience in medical device regulatory submissions and played a key role in securing the approval of novel absorbable implants, surgical staplers, orthopaedic implants, diagnostic devices, neurological devices and combination products, including drug eluting stents. He also played a leadership role in establishing a global regulatory strategy for these products that provided for timely approvals in the Asia Pacific markets. He has been active with industry associations in the areas of product approval and FDA legislation working on every amendment to the medical device provisions of the US Food Drug and Cosmetic Act since 1980. He was also active in shaping the Medical Device Directive in the EU as well.
Bob has been closely involved in several of the Endeavour II LP investments including Nfocus, Symetis and CeQur. He is currently a Board Member for CeQur and Vice President for Regulatory Affairs. Bob is also a Board Member for Insite Vision Inc.
In 2002, Bob was awarded the Richard E. Greco Award, the highest honour bestowed by the Regulatory Affairs Professionals Society (RAPS) and was then Chairman of the society in 2006. Bob was also a member of the Food and Drug Law Institute’s Medical Devices committee and an industry representative to the FDA’s General and Plastic Surgery Advisory Panel. Bob has been honoured as an AdvaMed Achiever in recognition of his contributions on behalf of the medical device industry and has served on numerous AdvaMed Working Groups. He chaired the AdvaMed Technology and Regulatory Committee for 13 years in addition to playing key roles in over 20 other working groups. He chaired the User Fee Committee at AdvaMed for the first three user fee negotiations with FDA. Bob has also testified before the US Congress and Senate as well as EU authorities on various regulatory issues.
Bob graduated in Biology from Upsala College, US and then completed an MBA at Fairleigh, Dickinson University, US.
Bob holds a patent for an absorbable stable design and given his extensive knowledge of the sector, he is the author of several articles and book chapters on regulatory issues. He has also written several publications regarding health products.