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

📌 Regulatory Specialist (Bengaluru)
🏢 Teleradiology Solutions
📍 Bengaluru