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 Ms. Dineen is a seasoned regulatory and clinical affairs professional with nearly 20 years experience in the start-up medical device company environment. She has a proven ability to drive the regulatory process, both as a direct employee and as a consultant. Her experience includes cardiovascular and gynecological device regulatory approvals, helping to grow companies from early start up to viable companies. She developed and implemented regulatory and clinical strategies for ten successful device approvals, three of which were novel first-of-a-kind devices. Prior to working as a consultant, Ms. Dineen worked at the Foundry, LLC as Vice President of Clinical Research and Regulatory Affairs. Before that, she held positions including Vice President, Clinical Research and Regulatory Affairs at EMBOL-X, Inc., Director of Clinical Research and Regulatory Affairs at Conceptus, Inc. where she was a Charter Member of the start-up, and various Clinical Research and Regulatory Affairs positions at Target Therapeutics, Inc. Ms. Dineen holds a BA in Organizational Psychology from the University of California. She attended the Stanford University Professional Education, Executive Program, and is Certified by the Regulatory Affairs Professional Society Board.
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