Regulatory Strategy Lead – Medical Devices & IVDs

Andaman Medical; Singapore; On-site; SGD 90,000 - 150,000; Full time

Job summary

Andaman Medical in Singapore seeks an experienced Regulatory Affairs professional to lead medical device submissions, registrations, and life-cycle changes. The role involves liaising with MOH, preparing applications, and guiding clients through regulatory pathways.

You will maintain regulatory databases, produce intelligence reports, and support the sales team on regulatory matters. Fluency in English and Mandarin, plus at least five years in the field, are essential for success in this

Qualifications

• Bachelor’s degree or higher in life sciences or pharmacy; registered pharmacist preferred.
• Minimum 5 years regulatory affairs experience in medical devices/IVD, supplements, cosmetics.
• Experience in client-facing consulting or business development is desirable.
• Fluent in English and Mandarin; strong writing and verbal communication.
• Self-driven, autonomous, able to work in a small start-up like structure.

Responsibilities

• Investigating regulatory classification and MOH submission routes for health products.
• Prepare and submit medical device registrations, including renewals and change notifications.
• Inform manufacturers promptly about feedback from authorities.
• Liaise with customers on regulatory concerns.
• Maintain regulatory database for the company.
• Prepare Regulatory Intelligence reports.
• Monitor regulatory trends and draft updates for Marketing Manager.
• Assist sales in regulatory discussions with clients.
• Develop and maintain SOPs and regulatory policies.
• Liaise with external parties on regulatory requirements.
• Report post-marketing activities to Authority (e.g., PSUR, recalls).
• Collaborate with Sales/BD for client pitches and regulatory pathways.
• Ensure awareness of regulatory obligations across supply chain.

Skills

Regulatory affairs

Client-facing

Regulatory intelligence

English language

Mandarin

Education

Bachelor’s Degree or higher in Life Sciences

Tools

Microsoft Office

Job description

Andaman Medical in Singapore seeks an experienced Regulatory Affairs professional to lead medical device submissions, registrations, and life-cycle changes. The role involves liaising with MOH, preparing applications, and guiding clients through regulatory pathways.

You will maintain regulatory databases, produce intelligence reports, and support the sales team on regulatory matters. Fluency in English and Mandarin, plus at least five years in the field, are essential for success in this