Senior Regulatory Affairs Program Manager (Koren speaking)

The Senior Regulatory Affairs Program Manager at Sonio is responsible for developing and executing regulatory strategies for AI/ML-enabled medical devices, ensuring compliance with FDA and other regulatory bodies for global market access. This role involves preparing high-quality premarket submissions, acting as a subject matter expert on relevant regulations, and managing communications with regulatory agencies. The position requires strong expertise in regulatory affairs within the medical device industry, particularly regarding software-based devices, and involves initial work in Paris or Boston before transitioning to Seoul, Korea. Fluency in English and Korean is essential for effective communication and collaboration.