Medical Device Documentation Specialist

2 weeks ago


kanpur, India beBeeRegulatory Full time

Regulatory Writer for Medical Device ProjectsWe are seeking a skilled Regulatory Writer to join our scientific operations team.This is a full-time, site-based role on a 12-month fixed-term contract with the potential for extension.Create, update, and manage regulatory documents, including 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 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.RequirementsBachelor's degree in a relevant field (e.g. life sciences, English)Minimum 3 years of experience in regulatory writing or a related roleFamiliarity with CER regulatory requirements, evidence generation, and literature reviewsBenefitsThis is an exciting opportunity to contribute to regulatory and scientific documentation within the medical device sector while working in a collaborative environment.



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