Senior Regulatory Affairs Specialist

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

• Investigating whether the Health Product is a medical device requiring registration with MOH, determining its risk classification and its route of submission.
• Preparing and submitting applications related to Initial, Renewal, Change Notification of medical device submissions, including follow up until approval.
• Promptly inform manufacturer is there’s any feedback from Authority to ensure successful product registration.
• Communicating with customers in respond to their regulatory concerns.
• Maintain regulatory database for the Company.
• Preparation of Regulatory Intelligence Report by carrying out proper research relating to the regulatory intelligence topic.
• Monitoring emerging trends regarding industry regulations to determine potential impact on internal projects and providing and drafting regulatory updates to Marketing Manager.
• Assist sales team in discussion with client on regulatory related matters (when required).
• Developing and maintaining Standard Operating Procedures, local working practices, regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Liaising with external parties on matters relating to medical device regulatory requirements.
• Carry out the reporting of post-marketing activities with Authority such as mandatory problem reporting, field safety correction action, recall and others.
• Partnering closely with the Sales and Business Development teams to participate in client pitches, draft commercial proposals, and present strategic regulatory pathways to prospective clients.
• Ensuring the awareness on obligations to comply with regulatory requirements and any other applicable statutory requirements and any decision thereof made by top management throughout the establishment and supply chain.

Qualifications

• At least a Bachelor’s Degree, Post-Graduate Diploma, Professional Degree, Biology, Chemistry, Pharmacy/Pharmacology, Biotechnology, or equivalent. Graduated as pharmacist/apothecary.
• Minimum of 5 years of regulatory affairs experience in medical devices and /or IVD’s, food supplements and cosmetics.
• Proven experience or strong aptitude in a client-facing, consulting, or business development role within the life sciences or healthcare industry is highly desirable..
• Fluent English and Mandarin with excellent writing and verbal communication skills
• Result oriented, can work with minimal supervision, and willing to assume increasing levels of responsibilities.
• Computer literate with advanced skills in Microsoft Office (Word, Power Point, etc.)
• At ease in working in a small structure, start-up-type, where tasks and responsibilities are in constant move.
• Able to operate in a multicultural environment.
• High level of autonomy at work, yet with profound team-spirit and a growth-oriented mindset.