Regulatory Affairs Specialist (Medical Device / FDA 510(k), EU MDR / 5 Days Office Hours)

About the Role

We are looking for a Regulatory Affairs Specialist to support global regulatory activities within the medical device industry. This role provides strong exposure to FDA submissions, EU MDR compliance, and international market registrations, working closely with cross-functional teams to ensure timely and compliant product launches.

• Provide regulatory strategy and guidance to product development teams, supporting product planning and pre-market activities
• Prepare, submit, and maintain regulatory filings including U.S. FDA 510(k), EU Technical Files/Design Dossiers, and other global submissions
• Liaise with global regulatory authorities for registrations, renewals, and variations to ensure continued market access
• Monitor and interpret evolving regulatory requirements (FDA, EU MDR, ISO), and perform gap analysis and impact assessments
• Maintain and manage product registration databases, ensuring accurate tracking of submissions and approvals
• Support regulatory compliance throughout the full product lifecycle (development to post-market)
• Handle Medical Device Reporting (MDR) and Vigilance reporting, including support for field safety corrective actions (FSCA) and recalls
• Collaborate with internal stakeholders (R&D, Quality, Project teams) and external partners to ensure compliance
• Perform other regulatory or project-related tasks as assigned

Business Edge Personnel Services Singapore

EA Personnel Reg No: R26159908 (Tan Ying Ying)