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Ruthie AMIR

Industry Representative
Israel

Chief Medical and Regulatory Officer for several companies (including Alon MedTech Ventures, Epitommee Medical and Sofwave Medical). Directing all clinical and regulatory activities.  Responsible for the development, implementation, and evolution of effective product approval processes. Key liaison with the FDA and international regulatory bodies in assuring regulatory compliance with clinical and product approval processes.  Responsible for the management and implementation of regulatory submissions activities that result in market leading, high quality medical device products that meet worldwide customer requirements.  Responsible for the global clinical research activities across the companies including feasibility, research, regulatory and marketing studies. Responsible for the development of key opinion leaders’ (KOL) and scientific collaboration with academic institutions worldwide. Responsible for scientific peer reviewed publications and global clinical presence in worldwide medical and aesthetic conferences and meetings.  

Education and fellowships: B.Med.Sc. and M.D. with honors (Ben-Gurion University Medical School, Beer-Sheva, Israel). Post-doctoral at the Technion – Israel Institute of Technology – Faculty of Medicine (Haifa, Israel). Fellowship on Molecular Studies in Rett Syndrome (from Baylor College of Medicine, Houston, Texas, USA) and Ali Kaufman Fellowship, Faculty of Medicine, Technion – Israel Institute of Technology, Haifa, Israel.

Experience:  Director, Genetics and Molecular Biology, The Zinman College of Physical Education and Sport sciences in the Wingate Institute (2005-2008); Global Vice President of Clinical Affairs at Syneron- Candela (2008-2013) and Global Vice President of Clinical and Regulatory Affairs and Professional Education at Syneron-candela (2013-2017). Since 2017, serves as Chief Medical and Regulatory Officer for several companies (as detailed above).

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