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....