Employer requires a Masters degree in a scienceany or related technical field plus 60 months experience in job offered, or related technical occupation. Education or experience must include 1 Specialized knowledge on medical device regulations and guidance issued from a regulatory body Pharmaceutical and Medical Device Act Ministry of Health, Labour and Welfare guidance, FDA guidance, 2 Specialized proprietary product and system knowledge related to the design, manufacturing, and procedure of devices in cardiac rhythm management and interventional cardiology division Subcutaneous ICD, Transcatheter aortic valve replacement, Left atrial appendage closure, and Cerebral embolic protection devices as well as relevant ancillary devices, 3 Document control system and regulatory record database Windchill system, RegIS, 4 Bench functional testing, biocompatibility testing, finite element analysis, structural reliability, preclinical animal model testing, virus inactivation testing, and human clinical trials, and 5 Lab techniques Cell Culture, ELISA, DNARNA extraction, Molecular Cloning, PCR, Virus PropagationTitration.
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