Paul brings 30 years of experience in the field of medical device regulatory affairs, quality assurance and clinical operations. Prior to joining the company, he managed 10 first-in-human trials in the USA and in Europe, conducted 5 Early Feasibility Studies (EFS) in conjunction with FDA and 5 CE Mark trials, and obtained more than 20 CE Marks and 15 Premarket Approvals (PMA) from FDA. During his 30-year career, he has gained a unique expertise in implantable cardiac devices. Former VP RAQACA of CardiAQ Valve Technologies, a transcatheter valve start-up acquired by Edwards Lifesciences for $350 million, he has also developed an extensive knowledge of cardiac assist devices (first at Arrow, then at Abbott as a consultant) and cardiac active implantable medical devices (notably at Telectronics, now Abbott’s Cardiac Rhythm Management division). He holds a Master’s degree in Engineering from the University of Pennsylvania (The School of Engineering and Applied Science, and The Wharton School).
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