APAC RAQA Specialist — Medical Devices

Applied Medical; Singapore; On-site; SGD 65,000 - 90,000; Full time

Benefits offered by this job

Benefits package

Job summary

Applied Medical is expanding its APAC Regulatory Affairs and Quality Assurance (RAQA) team. The RAQA Specialist will help registrations, maintain QMS documents, and support post-market activities including AE/FSCA recalls.

The role liaises with regional teams, distributors, and authorities to ensure regulatory compliance and continued market access across APAC in a medical device environment.

Qualifications

• Bachelor’s degree in engineering, physical or biological sciences, regulatory, or other technical discipline.
• 1–2 years of experience in Regulatory Affairs and/or Quality Assurance in the medical device industry.
• Training in Quality Systems including GDPMDS (GDPMD/GDPMDS).
• Ability to work independently and as part of a team.
• Analytical, meticulous and detail oriented with strong communication.

Responsibilities

• Support regulatory registrations across APAC by compiling dossiers per local regulations.
• Maintain and support the Quality Management System (QMS) activities and documentation.
• Assist with post-market activities including adverse events and recalls reporting.
• Participate in internal and external audits and maintain regulatory databases.
• Coordinate with regional teams, distributors, and regulatory authorities to ensure ongoing market access.

Job description

Applied Medical is expanding its APAC Regulatory Affairs and Quality Assurance (RAQA) team. The RAQA Specialist will help registrations, maintain QMS documents, and support post-market activities including AE/FSCA recalls.

The role liaises with regional teams, distributors, and authorities to ensure regulatory compliance and continued market access across APAC in a medical device environment.