Medical Document Specialist

2 days ago


kottayam, India beBeeDocumentation Full time

Job OverviewThis role presents an exciting opportunity for a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector in a collaborative, cross-functional environment.Key Responsibilities:Develop and update Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (SLRs) in compliance with applicable regulatory requirements and guidelines.Participate in all core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesis.Analyze clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devices.Compare device safety and performance against the state of the art and investigate unexpected outcomes.Utilize various software systems, including Microsoft Office, EndNote, Distiller, Wrike, and in-house AI tools, to create required documents.The ideal candidate will have excellent research and writing skills, strong attention to detail, and the ability to work effectively in a team environment.



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