The posting
We are seeking an experienced and proactive Regulatory Affairs / Government Affairs Specialist to join our Singapore-based regional hub.
The successful candidate will be responsible for regulatory registration and compliance activities across assigned Southeast Asian markets, while also building and maintaining relationships with regulatory authorities and government agencies. Over time, and subject to performance and readiness, the candidate will take on increasing responsibility, including team leadership and strategic government engagement.
We are looking for someone with strong regulatory expertise, a developing network within regulatory authorities across the region, and the capability to eventually lead the RA function and serve as the company's primary interface with government agencies and policymakers.
Key Responsibilities
Regulatory Affairs
- Lead end-to-end regulatory registration activities for Class C medical devices across assigned Southeast Asian markets, including regulatory strategy, technical documentation, product testing, clinical evaluations, quality system documentation, and submissions.
- Manage regulatory registrations, renewals, amendments, and change notifications for assigned markets.
- Prepare and submit regulatory filings in accordance with the requirements of the assigned region(s).
- Act as the primary liaison with regulatory authorities, notified bodies, and local registration partners to facilitate timely approvals and address regulatory inquiries.
- Monitor submission timelines and proactively manage regulatory milestones to support product launches and lifecycle management.
- Maintain accurate and up-to-date regulatory documentation, technical files, product registrations, and regulatory records.
- Monitor changes to applicable regulations within assigned markets and assess their impact on existing and future products.
Government Affairs & Authority Engagement
- Build and maintain constructive relationships with key regulatory bodies, including HSA (Singapore), MDA (Malaysia), Thai FDA, BPOM (Indonesia), Philippines FDA, and Vietnam MOH, among others.
- Represent the company in industry associations, trade groups, and multi-stakeholder forums to advocate for favorable regulatory policies and harmonization initiatives.
- Monitor and analyze the political, legislative, and regulatory landscape across assigned markets, providing strategic counsel to senior management on risks and opportunities.
- Support advocacy efforts on key policy issues, including regulatory reliance programs, ASEAN harmonization initiatives, and market access reforms.
- Prepare and deliver position papers, consultation responses, and policy briefs to government agencies and industry bodies.
Cross-Functional Collaboration & Strategic Support
- Collaborate closely with internal teams, including Quality Assurance, Clinical Affairs, Market Access, Commercial, and Legal, to ensure regulatory and quality compliance throughout the product lifecycle.
- Provide regulatory guidance on product development, labeling, design changes, and market entry strategies.
- Partner with Market Access and Government Affairs colleagues to align regulatory strategy with reimbursement and policy goals.
- Support business development activities by providing regulatory due diligence and market entry assessments for new products or markets.
- Serve as a subject matter expert on regulatory and government affairs matters for internal stakeholders.
Compliance & Documentation
- Ensure all regulatory activities comply with applicable local, regional, and international regulations and standards.
- Maintain accurate and up-to-date regulatory documentation, technical files, product registrations, and government engagement records.
- Oversee the preparation and submission of regulatory filings, renewals, amendments, and change notifications for assigned markets.
- Manage regulatory milestones and submission timelines to support product launches and lifecycle management.
Candidate Requirements
- Bachelor's Degree in Life Sciences, Biomedical Engineering, Engineering, Public Health, Health Policy, or a related discipline.
- Minimum 5-7 years of Regulatory Affairs experience within the medical device industry, with at least 1-2 years in a team leadership or management role.
- Hands-on experience with Class C medical devices is required.
- Proven experience managing end-to-end product registrations, renewals, change notifications, and regulatory lifecycle activities across multiple Southeast Asian markets.
- Demonstrated experience or exposure to Government Affairs, public policy, or authority engagement within the healthcare or medical device sector.
- Established working relationships with regulatory authorities and government agencies across Southeast Asia (e.g., HSA, MDA, Thai FDA, BPOM, Philippines FDA) is highly preferred.
- Excellent organizational, analytical, and project management skills, with the ability to manage multiple regulatory submissions and government engagements simultaneously.
- Strong written and verbal communication skills in English. Proficiency in an additional language is an advantage.
- Prior experience mentoring or guiding junior team members is an advantage.
- Demonstrated leadership potential and a desire to grow into a people management role.
- Demonstrated ability to influence and negotiate with senior government officials and external stakeholders.
- Self-motivated, detail-oriented, and able to work effectively in a cross-functional, international environment.
- Willingness to travel within the region as required.
