Job Title: Regulatory & Technical Writer

Experience

1–2 years (hands-on ownership in Regulatory [CDSCO, ISO, FDA] documentation)

About the Role

We 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 Responsibilities

- Author, review, and maintain regulatory documentation for AI/ML-based medical devices and SaMD
- Support FDA submissions (e.g., 510(k), De Novo, PMA) and EU MDR technical documentation
- Develop and maintain documents including:

- Software Description and Architecture

- AI/ML model lifecycle documentation
- Risk management files (ISO 14971)
- Software Development Life Cycle (IEC 62304)
- Usability engineering documentation (IEC 62366)
- Clinical evaluation support documentation
- Model performance, validation, and verification reports
- Change management and traceability documentation
- Document AI model training data, data governance, bias considerations, and performance monitoring
- Collaborate with Regulatory Affairs, Quality, AI engineers, and Product teams to ensure alignment with regulatory expectations
- Ensure traceability between requirements, design, implementation, verification, and validation artifacts
- Support audits, inspections, and regulatory questions by providing transparent and defensible documentation
- Maintain documentation in accordance with Quality Management Systems (QMS)





Required Qualifications

- Bachelor’s degree in Technical Communication, Biomedical Engineering, Computer Science, Life Sciences, or related field
- 3+ years of experience writing regulatory or quality documentation for medical devices or SaMD
- Hands-on experience with FDA and/or EU MDR regulatory submissions
- Strong understanding of regulated documentation requirements and controlled document processes
- Excellent technical writing, editing, and document management skills
- Experience working within a QMS (ISO 13485 preferred)

Preferred Qualifications

- Experience documenting AI/ML systems in regulated healthcare environments

- Familiarity with
- FDA guidance on AI/ML-enabled medical devices
- EU MDR Annex II & III Technical Documentation
- GMLP (Good Machine Learning Practice)
- Understanding of model validation, dataset documentation, and post-market surveillance for AI systems
- Experience collaborating with Regulatory Affairs and Quality teams
- Familiarity with tools such as eQMS, document control systems, and requirements management tools

Nice to Have

- Experience with clinical AI, imaging AI, or decision support systems
- Exposure to cybersecurity documentation (FDA, IEC 81001-5-1)
- Ability to create traceability matrices, diagrams, and regulatory-ready visuals
- Prior experience supporting audits or regulatory inspections

What We Offer

- Opportunity to work on AI technologies that impact patient care
- High ownership role in regulatory readiness and compliance strategy
- Collaborative environment with AI, clinical, and regulatory experts
- Competitive compensation and benefits
- Flexible work arrangements

Must 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

📌 Regulatory Specialist (Bengaluru)
🏢 Teleradiology Solutions
📍 Bengaluru