Must have a Masters degree in Biomaterials Engineering, Cell Biology, Chemistry, Materials Science, Microbiology or related field and 10 years of experience in the field of medical devices or other regulated industry or related field. Must have 3 years of experience evaluating the biological safety of devices; Must have 5 years of experience authoring and reviewingapproving protocols describing test sample selection with appropriate controls; rationale and description of selected test methods; Must have 5 years of experience in interpretation and analysis of test data to generate detailed test reports; and Must have 3 years of experience presenting biological safety risk assessments and test data to technical audience and expert groups and key opinion leaders.
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