Bachelors degree in Biomedical Engineering, Biotechnology or closely related field willing to accept foreign education equivalent plus seven 7 years of experience in job or relevant qualityregulatory affairs, scientific or engineering management, or alternatively a Masters and four 4 years of experience; or Ph.D and two 2 years of experience as stated. Experience must include Quality assurance processes experience with medical device industry with an analytical and organized approach; working on domestic and international quality systems and other standards such as FDA QSR, MDD, CMDCAS, SFDA, JPAL, ISO 13485, ISO 14971, World Health Organization or other applicable standards and regulations; leading cross functional teams through complex technical investigations; three 3 years of CAPA experience in the medical device industry two 2 years with PhD. Up to 25 travel required.
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