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 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 explicit and defensible documentation
- Maintain documentation in accordance with Qual

📌 Regulatory & Technical Writer (Bengaluru)
🏢 Teleradiology Solutions (TRS)
📍 Bengaluru