Tamar Katzav
VP Project Management, Medical Device Practice at Physio-Logic Ltd
Based in Israel
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Seniority
Vp
Department
Other
Location
Israel
Industry
Medical Equipment Manufacturing
Company size
31
Contact information
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t•••••••@physio-logic.co.il
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Background
About Tamar Katzav
Medical device experience in compliance of quality management systems (QMS) to the current ISO13485:2016 version and MDSAP certification. • Global Regulatory Affairs manager with extensive experience and knowledge of international pharmaceutical regulatory registration. • Experience in many aspects of medical device registration including preparation of 510K submission and Technical File. • Extensive knowledge of GMP regulation, Quality Assurance and compliance including experience with FDA inspections, notified body and ISS. • Over 15 years of biological research experience including monoclonal antibodies studies, chemical ecology, biosynthesis of glandular secretion and behavioral research. • Excellent Stakeholder Management skills by partnering and collaborating with key stakeholders, and analyzing complex data. • Strong Leadership and Management skills. Providing guidance and support to successful international teams empowered to take ownership and responsibility.
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