Found Description
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