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Telradsol is hiring a Regulatory and Technical Writer in Bangalore North to support regulatory and compliance documentation for AI-enabled medical devices and Software as a Medical Device (SaMD). This is an excellent opportunity for professionals with experience in FDA, EU MDR, CDSCO, and ISO documentation, especially those interested in AI/ML regulatory frameworks.
The role involves close collaboration with AI engineers, regulatory affairs, quality, and clinical teams to ensure global regulatory compliance and audit readiness.
🔑 Key Responsibilities – Regulatory & Technical Writer
- Author, review, and maintain regulatory documentation for AI/ML-based medical devices and SaMD
- Support FDA submissions including 510(k), De Novo, and PMA
- Prepare and manage EU MDR Annex II & III Technical Documentation
- Develop documentation such as:
- Software description & architecture documents
- AI/ML model lifecycle documentation
- Risk Management Files (ISO 14971)
- Software lifecycle documentation (IEC 62304)
- Usability engineering files (IEC 62366)
- Clinical evaluation support documents
- Validation, verification, and model performance reports
- Ensure end-to-end traceability between requirements, design, testing, and validation
- Document AI training datasets, data governance, bias assessment, and post-market monitoring
- Support regulatory audits and inspections with defensible documentation
- Maintain documentation in compliance with QMS (ISO 13485)
🎓 Required Qualifications
- Bachelor’s degree in Technical Communication, Biomedical Engineering, Computer Science, Life Sciences, or related field
- 1–3 years of hands-on experience in regulatory or technical writing
- Exposure to FDA, EU MDR, CDSCO, and ISO documentation
- Experience working within a controlled document and QMS environment
- Strong technical writing, editing, and documentation management skills
⭐ Preferred Qualifications
- Experience documenting AI/ML systems in regulated healthcare environments
- Familiarity with:
- FDA guidance on AI/ML-enabled medical devices
- GMLP (Good Machine Learning Practices)
- EU MDR regulatory framework for AI
- Understanding of model validation, dataset documentation, and post-market surveillance
- Experience with eQMS, document control systems, and requirements management tools
➕ Nice to Have Skills
- Experience in clinical AI, imaging AI, or decision support systems
- Exposure to cybersecurity documentation (FDA, IEC 81001-5-1)
- Ability to create traceability matrices, regulatory diagrams, and visuals
- Participation in at least two regulatory audits
💼 Salary & Benefits
- Estimated Salary: ₹6,00,000 – ₹10,00,000 per annum (based on experience)
- High-ownership role in AI regulatory compliance
- Opportunity to work on cutting-edge AI healthcare technologies
- Collaborative environment with regulatory, AI, and clinical experts
- Competitive compensation and flexible work arrangements
📍 Job Location & Work Mode
- Location: Bangalore North, Karnataka
- Work Mode: Work From Office (WFO)
- Eligibility: Only Bangalore-based candidates
📧 How to Apply
Interested and eligible candidates can apply by sending their updated CV to:
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📩 Email: nanda.k@telradsol.com
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