First, we have Arthur (Art) Kawasaki, who brings over 29 years of rich experience in Regulatory Affairs, Quality, and Clinical Affairs across the pharmaceutical, biologics, medical devices, and IVD industries. Art has demonstrated his leadership and expertise at several prominent organizations, including Eli Lilly, Becton Dickinson, Canon Biomedical, DiaSorin Molecular, and most recently at Exact Sciences as the Vice President of Regulatory Affairs. He holds both a Master of Science in Physiology and an MBA in Marketing from prestigious Canadian universities.
Joining Art is Dr. Kandarp Shah, a seasoned professional with eight years of focused experience in handling US 510(k) and PMA applicable products, including IDE approvals and EU IVDR/MDR/CE marking. His work has spanned worldwide registrations for IVD products and permanent implants. Kandarp also brings over a decade of experience in molecular and cellular biology, having contributed significantly to research in immunology and cardiovascular disease. His past roles at Carl Zeiss and Exact Sciences, among others, underscore his profound expertise and commitment to advancing medical science. |
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