Regulatory Documentation Specialist

5 days ago

thane, India beBeeWriter Full time

Job Title: Scientific Content SpecialistWe are seeking a detail-oriented professional to contribute to regulatory and scientific documentation within the medical device sector. This role involves creating, updating, and managing documents including Clinical Evaluation Reports, Summary of Safety and Clinical Performance Reports, State of the Art Reviews, and Systematic Literature Reviews.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 to create required documents.FOLLOW ALL COMPANY PROCEDURES AND GUIDELINES.Collaborate with cross-functional teams including Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs.Education & Experience Requirements:Bachelor's degree in Life Sciences or related field.Minimum 3 years' experience in medical writing or related roles.Experience in the medical device industry and knowledge of CER regulatory requirements, evidence generation, and literature reviews preferred.Strong oral communication, presentation, project management, and prioritization skills.Additional Qualifications/Desirable:Background in life sciences (Dentistry, Optometry, Veterinary Science, etc.) welcomed.Experience with CER creation, MEDDEV 2.7.1 rev 4, MDCG/MDR regulations considered a strong advantage.Proven ability to perform literature searches, summarize clinical conditions, and assess risks and benefits for medical devices.Experience reviewing supporting device documentation and analyzing device performance data.

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