Zürich Area, Switzerland
Associate Regulatory Affairs Manager at Stryker
Medical Devices
Education
San Jose State Uni. & San Jose City College California USA 1992 — 1994
CoA, Business Administration
Ankara University, Chemical Eng. Turkey 1986 — 1991
BSc, Chemical Engineering
Ankara University, British Literature Turkey 1983 — 1985
AA, British Literature
Experience
Stryker February 2014 - Present
BIOTRONIK Switzerland July 2012 - January 2014
Cochlear Belgium March 2011 - April 2012
Abbott Vascular San Francisco Bay Area CA USA October 2005 - March 2011
Varian Medical Systems San Francisco Bay Area CA USA October 2002 - October 2005
Skills
Biopharmaceuticals, GCP, Drug Development, Oncology, Hardware Diagnostics, Regulatory Requirements, Validation, Commercialization, CAPA, PMA, FDA GMP, Pharmacovigilance, Management, Clinical Development, Design Control, Change Control, CTMS, GLP, ISO 13485, Strategy, CE marking, Product Development, eCTD, V&V, Sop, FDA, Clinical Research, Technology Transfer, Lifesciences, Generic Programming, GxP, Regulatory Affairs, Combination Products, Medical Devices, GMP, ISO 14971, Pharmaceutics, IND, Regulations, Quality Auditing, Quality System, CRO, Regulatory Submissions, Pharmaceutical Industry, Biotechnology, R&D, Leadership, 21 CFR Part 11, Quality Assurance, Clinical Trials