About the Job
We are seeking a Senior Manager – Regulatory Affairs & Commercial Operations to join a leading regional medical technology commercialization and supply chain solutions organization. This is a strategic leadership opportunity for an experienced Regulatory Affairs professional with strong commercial acumen and operational leadership experience to build and scale a Regulatory-as-a-Service (RAaaS) business while overseeing regional procurement, vendor management, and supply chain operations.
In this highly visible role, you will lead the commercialization of regional regulatory capabilities into a revenue-generating service offering while ensuring operational excellence across purchasing, freight management, pricing governance, and vendor performance throughout the ASEAN region.
Reporting to: Managing Director
Work Mode: Onsite
Office Location: Selangor
Portfolio: Regulatory Affairs, Regulatory Commercialization (RAaaS), Commercial Operations, Supply Chain Operations, Procurement, Vendor Management, Pricing Governance, International Logistics
Culture: Entrepreneurial, customer-focused, collaborative, commercially driven, and operational excellence-oriented
The Role
1. Regulatory Commercialization & Business Growth
Lead the development and expansion of the organization's Regulatory-as-a-Service (RAaaS) business by transforming regional regulatory expertise into a scalable commercial offering for global medical device and healthcare principals entering ASEAN markets.
2. Regional Regulatory Affairs Leadership
Provide strategic leadership for multi-country medical device registrations, regulatory submissions, product lifecycle management, and regulatory compliance across ASEAN while maintaining strong relationships with regional health authorities.
3. Commercial Client Engagement
Serve as the primary regulatory expert for prospective and existing clients by presenting regulatory solutions, supporting business development activities, managing client relationships, and ensuring successful onboarding and long-term partnership growth.
4. Commercial Operations & Vendor Management
Lead regional Pricing & Vendor Management activities by overseeing transfer pricing structures, landed cost analysis, vendor negotiations, pricing governance, and supplier performance to optimize profitability and operational efficiency.
5. Purchase Order & Supply Chain Operations
Oversee end-to-end procurement, purchase order processing, freight coordination, and international logistics operations to ensure timely product availability, inventory flow, and customer fulfilment across ASEAN.
6. Supply Chain Compliance & Operational Excellence
Drive continuous improvement across supply chain operations by establishing operational KPIs, strengthening vendor governance, improving customs compliance, and resolving complex cross-border logistics challenges.
7. Leadership & Cross-Functional Collaboration
Lead and develop multidisciplinary teams across Regulatory Affairs, Quality Assurance, Supply Chain, Procurement, and Vendor Management while partnering closely with commercial, finance, operations, and country leadership teams to achieve strategic business objectives.
8. Strategic Transformation & Performance Management
Champion business transformation initiatives by implementing scalable processes, strengthening governance frameworks, monitoring operational and financial KPIs, and driving continuous improvement across regulatory and commercial operations.
Requirements
- Bachelor's Degree in Biomedical Science, Pharmacy, Supply Chain Management, Life Sciences, Engineering, or a related discipline
- Minimum 8–10 years of leadership experience within Regulatory Affairs, Quality Assurance, Commercial Supply Chain, Medical Device, MedTech, Healthcare Distribution, or Healthcare Sourcing industries
- Proven experience managing multi-country medical device registrations and regulatory submissions across ASEAN markets
- Strong knowledge of medical device regulatory frameworks including GDPMD, ISO 13485, and regional regulatory authorities such as Malaysia MDA, Singapore HSA, and other ASEAN agencies
- Demonstrated experience building relationships with regulatory authorities, distributors, principals, and external stakeholders
- Strong commercial mindset with the ability to translate technical regulatory expertise into customer-focused business solutions and revenue-generating services
- Proven people leadership experience managing cross-functional teams and driving organizational capability development
- Excellent stakeholder management, negotiation, presentation, and communication skills with the ability to engage senior executives and global business partners