Kevin is a consultant to the Office of Quality and Regulatory Services at the Jacobs Institute and has over 30 years of experience in US/International Regulatory, Clinical Affairs and Quality Assurance areas. Kevin started off his career as a cardiovascular technician at Brigham and Women’s Hospital, moved to industry and began his career in medical device development. His track record includes successful execution of both feasibility and pivotal phases of the MERCI Trial and navigating the FDA approval process for the first ischemic stroke device (Merci Retriever). Kevin has also worked extensively in the cardiovascular space on Class II and Class III medical devices (coronary/peripheral stents, heart failure). He has developed successful regulatory and clinical strategies to support both EFS and pivotal trials in the United States and abroad.
In his quality role, Kevin has successfully implemented Quality Systems to be compliance with ISO 13485:2016 and 21 CFR 820 across several small companies. Kevin has facilitated EU CE Mark of multiple Class III devices in the cardiovascular and neurovascular space. He has managed design verification and validation activities supporting both US and international regulatory approvals.