International Medical Device Regulatory Affairs Specialist

UROMEDTECH PTE. LTD.; Singapore; On-site; SGD 70,000 - 120,000; Full time

Job summary

UROMEDTECH PTE. LTD. based in Singapore is seeking a Regulatory Affairs Specialist to drive regulatory strategies for UroMedtech products across international markets.

The role focuses on preparing registrations, maintaining regulatory documents, responding to authority queries, and coordinating with distributors and in-country partners to support post-market compliance and product lifecycle management.

Qualifications

• Bachelor's degree required in a relevant science or engineering field.
• 3–6 years of Regulatory Affairs experience in medical-device industry.
• Experience preparing or supporting medical-device registration submissions.
• Familiar with ISO 13485, ISO 14971 and global regulatory frameworks.
• Experience coordinating regulatory submissions with internal and external partners.

Responsibilities

• Support and coordinate medical-device registrations across priority international markets.
• Prepare and maintain regulatory submission dossiers per country requirements.
• Coordinate registration activities with distributors and local representatives.
• Track submission status, queries, approvals, licence validity, renewal requirements.
• Prepare responses to authority questions with internal teams.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory submissions

Regulatory strategy

Education

Bachelor's degree in Biomedical Engineering

Bachelor's degree in Life Sciences

Bachelor's degree in Pharmacy

Bachelor's degree in Medical Science

Job description

UROMEDTECH PTE. LTD. based in Singapore is seeking a Regulatory Affairs Specialist to drive regulatory strategies for UroMedtech products across international markets.

The role focuses on preparing registrations, maintaining regulatory documents, responding to authority queries, and coordinating with distributors and in-country partners to support post-market compliance and product lifecycle management.