Tsvia Erlich, M.Sc., Regulatory Affairs & Clinical Research
Mrs. Erlich is a senior regulatory, clinical trials, and compliance expert for the health-care and medical device industry. She has served as a senior management member and held VP positions in national startups and international health-care companies since 2003. As part of her job, she managed large company teams, delineated the regulatory and compliance strategy and led its implementation, leading to multinational market clearance, including the EU, USA, South America and the Japanese market. She also designed and managed multinational multisets clinical trials and submissions. In addition, since 2001, she also served as a senior consultant in the PushMed group and N.G.I.T, for more than 70 medical device companies in miscellanies clinical fields. As a consultant she established quality systems, lead the design control process to support successful regulatory submissions, supported the company during CE audits and FDA inspections, and tailored regulatory and clinical strategy. She also held meetings with regulatory bodies, including notified bodies and FDA, and managed clearance file submissions, such as a Technical File, 510(k) notices and post market activities.
Tsvia Erlich joined ConTIPI Medical, as Regulatory and Clinical Affairs officer in 2007.
She holds a BSc. degree (cum laude) in Biochemistry and Food Engineering from the Hebrew University in Jerusalem. Later, she graduated the Technion Institute of Technology, Haifa and received her M.Sc. degree (cum laude) in Biotechnology and Food Engineering, in 1993. During that time she completed her research in the field of protein engineering at the laboratory of Professor Yuval Shoham, at Technion Institute.
She holds CQE and CQM certificates since 1999 and is an active member of RAPS and she lectures at national and international conferences.