Having more than 25 years of experience in the life science industry, mainly with medical device and IVD companies. I served as a senior management member and held VP positions in national, small, innovative startups and international health-care companies, engaged in miscellaneous clinical fields, including Cardiology, Oncology, Robotics, Digital Health, AI, Urology, Gynecology, Cell Therapy, Ophthalmology, Cosmetics, IVD, Diabetics, Orthopedics, home use devices, Wound healing, Surgery, Interventional Radiology and Microbiology.As part of my job duties, I have managed large company teams, delineated the regulatory and compliance strategy for various products and led its implementation, leading to multinational market clearance, including the EU, USA, South America and the Japanese market. I have also designed and managed multinational multisets clinical trials and submissions. In addition, I served as a senior consultant in the PushMed group for few years (back in 2001) and currently owns N.G.I.T Premium Consulting, for more than 70 medical device companies in miscellanies clinical fields. As a consultant I have established and maintained full quality management systems, lead the design control process to support successful regulatory submissions, developed labeling materials, conducted human factor studies, supported companies during CE audits and FDA inspections, and tailored regulatory and clinical strategies. I also assisted and held meetings with regulatory bodies, including notified bodies and FDA, and managed clearance file submissions, such as a Technical File, 510(k) notices, De-Novo and post market activities. In parallel to being a senior consultant, I serve as VP Regulatory and Clinical Affairs at ConTIPI Medical, since 2007.