Medical Device Documentation Specialist

3 days ago

Jodhpur, India beBeeDocumenter Full time

Regulatory and Scientific Documentation SpecialistWe are seeking a highly skilled Regulatory and Scientific Documentation Specialist to join our team supporting medical device projects.The successful candidate will create, update, and manage regulatory and clinical documents including Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance Reports (SSCPs), State of the Art Reviews (SOAs), and Systematic Literature Reviews (LRRs) within their assigned therapeutic area.Key Responsibilities:Write 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 documentsFollow all 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 AffairsCommunicate business-related issues or opportunities to management effectivelyRequirements:Bachelor's degree in a life science field (e.g. Dentistry, Optometry, Veterinary Science) or related fieldMinimum 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 is preferredStrong oral communication, presentation, project management, and prioritization skillsAdditional Qualifications:Background in clinical research, quality/regulatory compliance, and adverse event reporting is a plusExperience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations is considered a strong advantageProven ability to perform literature searches, summarize clinical conditions, and assess risks and benefits for medical devicesExperience reviewing supporting device documentation and analyzing device performance dataThis 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, cross-functional environment.

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