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Galit Shahaf

Galit Shahaf

VP QA & Eng, Sion Biotext Medical at Sion Medical Ltd.

Israel

Director of regulatory Affairs at medical device company - Responsible for all regulatory activities in the company including technical file (TF) preparation and maintenance, notifications and communication with regulatory authorities, implementation of regulatory requirements, preparation of regulatory documentation for regulatory submissions worldwide including Europe, Taiwan, Korea, Israel and FDA. Working closely with QA director on key quality assurance activities including ECO, customer complaints, CAPA, PMS, training, risk management, compliance and maintenance ISO13485.

Research Project Manager, at pharmaceutical company - management of complex projects in the field of Extractables & Leachables, Sterile Filtration, Foreign Particles, writing Risk Assessments & complex investigations reports, supporting RA department in Drug Product registration, working in a cGMP environment, guidance of team leaders and laboratory personnel.
CRA – Clinical Research Associate, monitoring of clinical trials- rich knowledge in the field of Clinical Trials, cGMP and ICH-GMP requirements for Drug Product and medical device registration.

Management of Academic Research laboratory – managing team of 12 researchers, management of multiple research projects, management of budget and purchasing, writing and implanting SOPs, teaching academic courses.
Management of academic research projects in the field of Biochemistry, Molecular Biology, Immunology of diabetes and transplantations. Rich experience in surgical procedures in rodents, Tissue Culture, FACS and proteins and Bioassays.



Experience:

  • Laboratory assistant instructer (Ben Gurion University)
  • VP QA & Eng, Sion Biotext Medical (Sion Medical Ltd.)
  • RA Manager (Integrity Applications (IGAP))
  • Research Laboratory Manager (Ben Gurion University)
  • Research Project Manager (KAMADA)
  • RA Director at Integrity Applications (IGAP) (Integrity Applications (IGAP))
  • Research Project Manager (KAMADA)
  • Post doctorate fellow , research (Ben Gurion University)

Skills:

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