Documenting Medical Innovation

2 weeks ago


kollam, India beBeeRegulatory Full time

Regulatory Documentation SpecialistThis is an exciting opportunity for a detail-oriented professional to contribute to high-quality, compliant documentation within the medical device sector while working in a collaborative 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)Participate in 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 to create required documentsAdhere to industry regulations, company procedures, and health, safety, and environmental practicesCollaborate with cross-functional teams to drive project successEducation & Experience Requirements:Bachelor's degree in a related field; advanced degree preferredMinimum of 3 years' experience in medical writing or related rolesExperience in the medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews preferred



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