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Kit joined Experien Group in 2006 and possesses 15+ years of medical device industry experience working for both start-ups and large public corporations. His professional background includes regulatory affairs, clinical research, product development, and sales and marketing. Kit has developed U.S. and international regulatory and clinical strategies for wide-ranging products and product lines. He has obtained numerous regulatory clearances and approvals from FDA and he has effectively managed Design Dossiers and Technical Files for CE Marking. Kit has been personally responsible for leading successful U.S. and OUS clinical trials, including the coordination and oversight of several OUS clinical research organizations.
At Experien Group, Kit is responsible for translating client companies’ strategic vision for their products into executable and commercially viable regulatory plans. He manages clients’ regulatory requirements for product development, manufacturing, submissions, and post-market compliance. He is responsible for formal and informal communications with global 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-IDE packages and client interface for pre-IDE meetings
- U.S. regulatory submissions (e.g., IDEs, 510(k)s, PMAs, and de novos)
- Design Dossiers and Technical Files for CE Marking
- Submissions for study authorizations (e.g., Institutional and Independent IRBs and Ethics Committees)
- Experien Group and client company representative at industry meetings and symposia
PAST COMPANIES AND EXPERIENCE
Kit has worked for several successful medical device companies, including Cardiometrics, CardioThoracic Systems, Converge Medical, Guidant, and Boston Scientific. He has particular expertise with cardiovascular and neurovascular medical devices. Prior to joining Experien Group, Kit was Boston Scientific’s Global Principal Product Manager for neurovascular access products. He designed, managed and supported numerous clinical trials of U.S. Class II and III medical devices for FDA submissions and reporting, including post-market trials. He additionally has directed numerous IRB, Ethics Committee, Notified Body, and FDA submissions, including 510(k)s and IDEs.
EDUCATION
Kit received a BS degree in Biological Sciences from Pepperdine University in Malibu, California. |
