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Sydney, Australia Australia

QA/RA Specialist at Hill-Rom, Welch Allyn and Trumpf

Well Qualified Regulatory and Quality Affairs professional with 5 years of strong Regulatory Affairs experience in the Medical Device Industry, dealing with regulatory, quality and effectiveness related issues. • Around 8 years of biomedical engineering experience including 5 years working at the Medical Device Department, Iranian FDA. • In-depth understanding of USFDA regulations (21 CFR part 800-1299) especially for CDRH and the European Union Medical Devices Directive (MDD) 93/42/EEC & Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC including amendments due to the Directive 2007/47/EC. • Understanding of the GHTF, Chinese SFDA, Korean KFDA, Japanese PMDA medical dev...