Clinical Documentation Specialist

5 days ago

kochi, India beBeeMedicalWriter Full time

Regulatory Document Specialist OpportunityThis 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.About the Role:We are seeking a highly skilled Regulatory Document Specialist to join our dynamic team supporting medical device projects. This is a full-time, site-based role with the potential for extension.The successful candidate will create, update, and manage a range of 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 guidelines.Participate in all core steps of 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.Utilize various software systems, including Microsoft Office, EndNote, Distiller, Wrike, and in-house AI tools, to create required documents.Follow all company procedures, regulatory guidelines, and health, safety, and environmental practices.Collaborate with cross-functional teams including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.Communicate business-related issues or opportunities to management effectively.Education & Experience Requirements:Bachelor's degree in a life science or related field is required, with advanced degree preferred.Minimum 3 years' experience in medical writing or related roles is necessary.Experience in the medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews is highly desirable.Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting is a plus.Strong oral communication, presentation, project management, and prioritization skills are essential.Additional Qualifications/Desirable:Background in life sciences is welcomed.Experience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations is considered a strong advantage.Proven ability to perform literature searches, summarize clinical conditions, and assess risks and benefits for medical devices is necessary.Experience reviewing supporting device documentation and analyzing device performance data is highly desirable.

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