Regulatory Affairs Manager

Regulatory Affairs Lead, Asia-Pacific

Location: Singapore

A globally recognized leader in advanced membrane technologies and biomaterials for medical applications is seeking a Regulatory Affairs Lead to join its Asia-Pacific team, based in Singapore.

This organization is at the forefront of developing innovative medical devices, including vascular grafts, surgical meshes, and implantable surgical components. These products play a critical role in improving patient outcomes and advancing modern healthcare.

The Regulatory Affairs Lead will oversee the regulatory function for the ASEAN and broader Asia-Pacific region. This leadership role is instrumental in driving regulatory strategies that enable timely market access, compliance, and sustainable growth in the region.

Key Responsibilities:

• Develop and implement regional regulatory strategies aligned with corporate goals.
• Lead submissions and manage interactions with regulatory authorities across APAC markets, including HSA, TGA, NMPA, PMDA, and others.
• Serve as the regulatory expert in cross-functional teams, including R&D, Quality, and Clinical Affairs.
• Monitor regulatory changes and ensure ongoing compliance across the product lifecycle.
• Represent the company in external industry forums and maintain high standards of regulatory integrity.

Candidate Profile:

• Minimum of 10 years of experience in regulatory affairs within the medical device industry.
• Strong knowledge of Asia-Pacific regulatory requirements and procedures.
• Proven ability to manage complex submissions and regulatory approvals across multiple jurisdictions.
• Demonstrated leadership, strategic thinking, and cross-functional collaboration skills.
• Strong written and verbal communication abilities.

What&aposs in it for you

• Opportunity to contribute to a high-impact, mission-driven organization.
• Competitive remuneration and comprehensive benefits.
• Exposure to cutting-edge medical technologies and a strong global team.
• A leadership position with significant influence and visibility across the region.

To express interest in this opportunity, please submit your application. All inquiries will be handled with the utmost confidentiality.

CEI: R2090154 | Licence No.: 22S1313