Regulatory Specialist

Job Title: Regulatory & Technical Writer Experience 12 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 manage...