Prepares clinical research documents to support regulatory registrations for medical device product development including literature reviews, clinical evaluation plans (CEPs) and reports (CERs), post-market clinical follow-up evaluation reports (PMCFERs), summary of safety and clinical performance (SSCPs) and other clinical documents as needed.
Communicates cross-functionally with key members of the project core team including clinical project leads, clinical trial leads, R&D scientists, project managers, regulatory associates, risk management, and medical safety, to incorporate appropriate content into clinical documentation and technical files.
Conduct literature searches, generate literature search protocols, review/assess results, summarize/analyze relevant clinical literature) including identification of new risks/hazards (vs. risk assessments) relevant to product(s) under evaluation.
Employment Type
Remote
Company Industry
Medical / Healthcare / Diagnostics / Medical Devices
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