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Experience
Experienced
About the role
This senior role sits within a global regulatory affairs organisation, acting as the strategic regulatory partner for supply chain transformation. You will shape regulatory strategy for major operational initiatives and make sure regulatory factors are considered in business decisions and project governance from the outset. It suits an experienced regulatory professional who enjoys leading complex cross-functional work in a global, matrixed environment.
What you'll do
Represent Regulatory Affairs in global supply chain strategic project teams, contributing regulatory insight to planning, governance and decisions.
Develop regulatory strategies for manufacturing changes, site transfers, new sites, sourcing and supplier changes, packaging modifications, process changes and distribution strategies.
Senior Manager, Regulatory Affairs - Global Supply Chain Transformation job at ResMed, Singapore | WorkJio
Lead global regulatory impact assessments and define the activities needed to support operational changes across affected markets.
Coordinate submissions, notifications, registrations and facility licences where applicable, ensuring consistent interpretation of global regulatory requirements.
Build regulatory considerations into project planning early to support informed decisions and reduce downstream risk.
Identify regulatory challenges before they become project risks or business escalations, and develop pragmatic mitigation strategies balancing compliance with business continuity.
Build trusted partnerships with senior leaders across Supply Chain, Quality, Manufacturing, Engineering and Regional Regulatory Affairs.
Establish and continuously improve the Regulatory Affairs operating model supporting supply chain projects.
Develop scalable processes, playbooks and tools for efficient and consistent execution of regulatory activities.
Build and maintain a knowledge-management framework for Supply Chain Regulatory Affairs.
Define and monitor KPIs that improve visibility, prioritisation and execution.
Lead and coordinate a global network of Regulatory Affairs subject-matter experts supporting supply chain initiatives.
Strengthen collaboration between global and regional Regulatory Affairs teams and create alignment across functions and markets.
Coach and guide regional teams and project members, contributing to organisational capability and future talent development.
Translate regulatory changes into clear business implications and strategic recommendations.
Ensure compliance with applicable international regulations while enabling efficient business execution.
Good to know
This position is based in Singapore.
The role may include direct people management as the organisation evolves.
Requirements
Bachelor's degree or higher in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs or a related discipline
At least eight to ten years of Regulatory Affairs experience in the medical device industry
Significant experience supporting global manufacturing changes, product lifecycle management, registrations, and Supply Chain or Operations projects
Knowledge of global medical device requirements including FDA, EU MDR, ISO 13485, Health Canada, TGA, ANVISA and other major frameworks
Strong understanding of regulatory change management and global registration strategies
Demonstrated success leading complex cross-functional projects in global organisations
Benefits
Challenging, supportive and inspiring career
Culture driven by excellence
Diverse and inclusive culture encouraging individual expression
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