Senior Advisor - Medtech
Mr. O’Holla was Worldwide Vice President of Regulatory Affairs for the Medical Devices and Diagnostics Group at Johnson & Johnson before retiring in May 2008 after 33 years of service.
He began his career in regulatory affairs in 1975 after spending several years in both medical device and drug development. Throughout 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 submissions and played a key role in securing the approval of novel absorbable implants, surgical staplers, orthopedic implants, diagnostic devices, neurological devices, and combination products, including drug eluting stents.
He has also been active with industry associations in the areas of product approval and FDA legislation and has worked 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.
Further, he has been honored 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. He served as the industry representative to the FDA’s General and Plastic Surgery Advisory Panel and has testified before the US Congress and Senate as well as EU authorities on various regulatory issues.
In 2002, Bob was awarded the Richard E. Greco Award, the highest honour bestowed by the Regulatory Affairs Professionals Society (RAPS). Bob served as chairman of the Regulatory Affairs Professional Society (RAPS) in 2006 and as a member of the Food and Drug Law Institute's Medical Devices Committee. He holds a patent for an absorbable stable design and is the author of several articles and book chapters on regulatory issues.
Currently, Mr O'Holla is a Director on the board of Insite Vision and also serves as the VP of Regulatory Affairs for CeQur and Nfocus neuromedical (both Endeavour Vision investments).
Mr. O’Holla holds an Associate degree from Union College, a Bachelor degree in Biology from Upsala College, and an MBA in General Management from Fairleigh Dickinson University.