Regulatory Affairs Specialist

Job Summary The Regulatory Affairs Specialist is responsible for managing medical device registration activities and ensuring regulatory compliance in Indonesia. This role works closely with local, regional, and global stakeholders to prepare and submit regulatory dossiers, maintain product registrations, and support the introduction of new products to the market. The incumbent will monitor regulatory requirements, coordinate with the Ministry of Health (MOH) and relevant authorities, and contribute to maintaining compliance with applicable medical device regulations and quality system requirements. This position offers valuable exposure to both local and global regulatory affairs within a dynamic international medical device environment.

Key Responsibilities Regulatory Registration & Submission Prepare, compile, review, and submit regulatory dossiers for medical device registrations, renewals, variations, and amendments in Indonesia.

Coordinate product registration activities with the Indonesian Ministry of Health (MOH) and other relevant regulatory authorities. Monitor registration timelines and proactively follow up with authorities to ensure timely approvals. Regulatory Compliance

Ensure compliance with applicable Indonesian medical device regulations and regulatory requirements. Maintain regulatory licenses, certificates, and product registration records. Monitor regulatory changes and assess their impact on existing products and business operations.

Cross-Functional Collaboration Liaise with global and regional Regulatory Affairs teams to obtain technical documentation and registration support materials. Work closely with Quality Assurance, Supply Chain, Manufacturing, and Commercial teams to support product launches and ongoing regulatory compliance.