Home > > Dorit Winitz, Ph.D.
Dorit is a regulatory and clinical affairs specialist, with over 15 years of experience in the regulated industry, focusing on medical devices, in vitro diagnostics, and combination products in a variety of medical fields and product types. At Medial EarlySign, Dorit has the overall responsibility for leading all aspects of global regulatory affairs, clinical affairs and quality systems for the company. Dorit held regulatory, clinical affairs and management positions in medical device companies and served as a senior regulatory and clinical affairs consultant at BioMedical Strategy (2004) Ltd. and Push-Med Ltd., both regulatory consultancy groups. Dorit accumulated vast experience in regulatory and clinical affairs and quality assurance, including the development and implementation of international regulatory strategies, design and preparation of regulatory submissions to global regulatory agencies, and planning and management of clinical studies, providing regulatory support across the full spectrum of product lifecycle. Dorit holds a BA in Chemistry and a Ph.D. in Biochemistry from Tel-Aviv University.