Regulatory Content Specialist

1 week ago

agra, India beBeeRegulatory Full time

Job Title: Regulatory Content SpecialistWe are seeking a highly skilled Regulatory Content Specialist to join our dynamic team.The successful candidate will create, update and manage regulatory and clinical documents including Clinical Evaluation Reports, Summary of Safety and Clinical Performance Reports, State of the Art Reviews and Systematic Literature Reviews within assigned therapeutic areas.Create and update CERs, SSCPs, SOAs and LRRs in compliance with applicable regulatory requirements and guidelinesParticipate in all 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 various software systems, including Microsoft Office, EndNote, Distiller, Wrike and in-house AI tools, to create required documentsThis is an exciting opportunity for a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector while working in a collaborative environment.Requirements:Bachelor’s degree in Life Sciences or related field; advanced degree preferredMinimum 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 preferredBenefits:This role offers a unique opportunity to work in a fast-paced and dynamic environment with a talented team of professionals. The ideal candidate will be motivated, proactive and have excellent communication and project management skills.About Us:We are a leading company in the medical device sector, committed to delivering high-quality products and services that improve patient outcomes. Our team is passionate about what we do and strive to make a positive impact in the world.

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