Medical Device Regulatory Affairs Strategist

Job description

As a Regulatory Affairs Specialist, you will support regulatory strategy and compliance for AI-enabled, cloud-native health software products across JAPAC markets. You will collaborate with product engineering, development, quality, legal, and cross-functional teams to assess product functionality, prepare and manage regulatory submissions, maintain required documentation, and support compliance throughout the product lifecycle, from development and launch through post-market activities. This role includes working with health authority requirements across countries such as Japan, Australia, Singapore, India, and other JAPAC markets, while providing regulatory guidance on product changes, labeling, audits, post-market surveillance, and evolving regulatory requirements.