Bilingual Medical Device Regulatory Specialist

ALCOTECH PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A specialist regulatory company in Singapore is looking for a Regulatory Affairs Specialist. The role includes preparing medical device registration dossiers for HSA and ensuring compliance with regulations. Ideal candidates have 2–5 years of regulatory affairs experience and strong knowledge of Singapore's medical device regulations. The job offers a salary range of $4,100 to $5,300 monthly and opportunities for professional growth.

Benefits

Career growth opportunities

Professional development

Qualifications

• Minimum 2–5 years of regulatory affairs experience.
• Strong knowledge of regulations from Health Sciences Authority (HSA).
• Experience with Therapeutic Products License (TPL) is preferred.

Responsibilities

• Prepare and submit medical device registration dossiers to HSA.
• Advise on regulatory strategy and compliance requirements.
• Monitor regulatory changes and ensure compliance.

Skills

Regulatory affairs experience

Knowledge of Singapore medical device regulations

Bilingual in English and Chinese

Organizational skills

Project management skills

Job description

A specialist regulatory company in Singapore is looking for a Regulatory Affairs Specialist. The role includes preparing medical device registration dossiers for HSA and ensuring compliance with regulations. Ideal candidates have 2–5 years of regulatory affairs experience and strong knowledge of Singapore's medical device regulations. The job offers a salary range of $4,100 to $5,300 monthly and opportunities for professional growth.