Senior Regulatory Content Specialist

13 hours ago


vijayawada, India beBeeRegulatory Full time

Regulatory Content WriterWe are seeking a skilled Regulatory Content Writer to create, update and manage regulatory documents within their assigned therapeutic area.Write and update Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs) and Systematic Literature Reviews (LRRs) 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.Summarize 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 software systems including Microsoft Office, EndNote, Distiller, Wrike and AI tools to create required documents.FOLLOW company procedures, regulatory guidelines and health, safety and environmental practices.Collaborate with cross-functional teams including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D and Regulatory Affairs.



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