Regulatory Document Specialist

1 week ago


Eluru, India beBeeMedical Full time

Regulatory Document SpecialistThe ideal candidate will create, update and manage key documents within their assigned therapeutic area.Create and revise regulatory documents in compliance with applicable requirements and guidelinesParticipate in systematic literature reviews including search, screening, data extraction, analysis and synthesisSummarize clinical, non-clinical and regulatory data for risk/benefit assessments on medical devicesKey Responsibilities:Develop high-quality regulatory documents, such as CERs, SSCPs, SOAs and LRRsCollaborate with cross-functional teams to ensure alignment and consistency in document developmentAnalyze and interpret complex data from literature reviews to inform document contentWhat We're Looking For:Strong research and analytical skills with ability to synthesize complex informationExcellent writing and communication skills with ability to adapt tone and styleAbility to work independently and collaboratively in a fast-paced environmentBenefits:Opportunity to develop expertise in regulatory document developmentCollaborative and dynamic work environmentProfessional growth and development opportunities



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