Scientific Documentalist

Regulatory Documentation SpecialistJob Title: Regulatory Documentation Specialist – Fixed Term Contract (12 months, Full Time)Locations: India, Mexico, BrazilDepartment: Scientific OperationsAbout the Role:We are seeking a highly skilled Regulatory Documentation Specialist to join our dynamic scientific operations team supporting medical device projects. This is a full-time, site-based role on a 12-month fixed-term contract with the potential for extension. The Regulatory Documentation Specialist 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:BA, BS, or BSN required; advanced degree preferred.Minimum of 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.Familiarity with clinical research, quality/regulatory compliance, and adverse event reporting is a plus.Strong oral communication, presentation, project management, and prioritization skills.This 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.