Document Controller

2 weeks ago


udaipur, India beBeeRegulatory Full time

Job OverviewThe role of a Regulatory Content Specialist involves creating, updating, and managing clinical documents including Clinical Evaluation Reports, Summary of Safety and Performance Reports, State of the Art Reviews, and Systematic Literature Reviews within their assigned therapeutic area.Develop and maintain regulatory content in compliance with applicable requirements and guidelinesParticipate in core steps of systematic literature reviews, including search, screening, data extraction, analysis, and synthesisSummarize clinical, non-clinical, and regulatory data to perform risk/benefit analyses on medical devicesCompare device safety and performance against the state of the art and investigate unexpected outcomesUtilize software systems, including Microsoft Office, EndNote, Distiller, Wrike, and AI tools, to create required documentsFollow company procedures, regulatory guidelines, and health, safety, and environmental practicesCollaborate with cross-functional teams, including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory AffairsEffectively communicate business-related issues or opportunities to management



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