Kit is a highly regarded medical device executive possessing 20 years of industry experience with both startups and large public corporations. His professional background includes senior management responsibility for regulatory affairs and clinical research as well as supporting roles in sales and marketing. Kit has successfully led wide-ranging device programs through development to global commercialization. He has been personally responsible for directing successful U.S. and OUS clinical trials and has secured numerous device approvals/clearances.
At Veranex, Kit is responsible for translating client companies’ strategic visions for their products into executable and commercially viable regulatory plans. He manages clients’ regulatory and clinical requirements to ensure alignment with quality management system requirements and operational efficiency. Kit is responsible for formal and informal communications with the FDA, notified bodies, and other regulatory agencies as well as all aspects of regulatory submissions. Kit’s primary functions include:
- Regulatory/clinical strategies
- Regulatory representative on client companies’ design teams for medical devices and combination products
- Pre-submission packages and client interface for FDA pre-submission meetings
- U.S. regulatory submissions (e.g., IDEs, 510(k)s, PMAs, and de novos)
- Designing dossiers and technical files for CE marking
- Clinical trial design and oversight (including feasibility studies, pivotal studies for commercial approval, and postmarket registry studies)
- Veranex and client company representative at industry meetings and symposia
Past companies and experience
Kit returned to Experien Group from SentreHEART where he was vice president of regulatory and clinical affairs. Prior to that, he was senior director of regulatory affairs and global management and board member at Acclarent, a Johnson & Johnson company. Kit previously held several senior positions at including vice president of regulatory affairs. Kit’s earlier career involved roles at several successful medical device companies, including Cardiometrics, CardioThoracic Systems, Converge Medical, Guidant, and Boston Scientific. He was Boston Scientific’s global principal product manager for neurovascular access products. Kit has particular expertise in cardiovascular and neurovascular medical devices.
Kit received a B.S. in biological sciences from Pepperdine University in Malibu, California.