Regulatory & Technical Writer

Telradsol | Full time Regulatory & Technical Writer Bangalore North, India | Posted on 07/14/2026 I'm interested Share job via email Share this job with your network Job listing Job details Job Information Industry Health Care Date Opened 07/14/2026 Job Type Full time Work Experience 1-3 years City Bangalore North State/Province Karnataka Country India Zip/Postal Code 560048 Job Description Job Title: Regulatory & Technical WriterExperience1–2 years (hands-on ownership in Regulatory [CDSCO, ISO, FDA] documentation)About the RoleWe are seeking an experienced Technical Writer to support our AI team with regulatory and compliance documentation for AI-enabled medical devices and software (SaMD). This role focuses on creating, maintaining, and managing documentation required for FDA submissions and EU MDR compliance, while collaborating closely with AI engineers, quality, regulatory affairs, and clinical teams.You will play a critical role in ensuring our AI systems are clearly documented, auditable, and compliant with global regulatory standards.Key ResponsibilitiesAuthor, review, and maintain regulatory documentation for AI/ML-based medical devices and SaMDSupport FDA submissions (e.g., 510(k), De Novo, PMA) and EU MDR technical documentationDevelop and maintain documents including:Software Description and ArchitectureAI/ML model lifecycle documentationRisk management files (ISO 14971)Software Development Life Cycle (IEC 62304)Usability engineering documentation (IEC 62366)Clinical evaluation support documentationModel performance, validation, and verification reportsChange management and traceability documentationDocument AI model training data, data governance, bias considerations, and performance monitoringCollaborate with Regulatory Affairs, Quality, AI engineers, and Product teams to ensure alignment with regulatory expectationsEnsure traceability between requirements, design, implementation, verification, and validation artifactsSupport audits, inspections, and regulatory questions by providing clear and defensible documentationMaintain documentation in accordance with Quality Management Systems (QMS)Required QualificationsBachelor’s degree in Technical Communication, Biomedical Engineering, Computer Science, Life Sciences, or related field3+ years of experience writing regulatory or quality documentation for medical devices or SaMDHands-on experience with FDA and/or EU MDR regulatory submissionsStrong understanding of regulated documentation requirements and controlled document processesExcellent technical writing, editing, and document management skillsExperience working within a QMS (ISO 13485 preferred)Preferred QualificationsExperience documenting AI/ML systems in regulated healthcare environmentsFamiliarity with:FDA guidance on AI/ML-enabled medical devicesEU MDR Annex II & III Technical DocumentationGMLP (Good Machine Learning Practice)Understanding of model validation, dataset documentation, and post-market surveillance for AI systemsExperience collaborating with Regulatory Affairs and Quality teamsFamiliarity with tools such as eQMS, document control systems, and requirements management toolsNice to HaveExperience with clinical AI, imaging AI, or decision support systemsExposure to cybersecurity documentation (FDA, IEC 81001-5-1)Ability to create traceability matrices, diagrams, and regulatory-ready visualsPrior experience supporting audits or regulatory inspectionsWhat We OfferOpportunity to work on AI technologies that impact patient careHigh ownership role in regulatory readiness and compliance strategyCollaborative environment with AI, clinical, and regulatory expertsCompetitive compensation and benefitsFlexible work arrangementsMust Have·        Exposure to the MDR AI framework is highly desirable. Also, a strong background in technical writing is required, with experience in participating in at least two audits  I'm interested