Clinical Documentation Expert

7 days ago


nellore, India beBeeMedicalWriter Full time

Regulatory Content Specialist Job DescriptionThe Regulatory Content Specialist will create, update, and manage critical documents including CERs, SSCPs, SOAs, and LRRs within their assigned therapeutic area.Key Responsibilities:Develop and revise CERs, SSCPs, SOAs, and LRRs in compliance with applicable regulatory requirements and guidelines.Participate in the 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 industry standards and investigate unexpected outcomes.Utilize various software systems, including Microsoft Office, EndNote, Distiller, Wrike, and AI tools, to produce required documents.Adhere to all 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.Effectively communicate business-related issues or opportunities to management.


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