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 o

📌 Regulatory Specialist (Bengaluru)
🏢 Telradsol
📍 Bengaluru