Senior Manager, Regulatory Affairs - Global Supply Chain Transformation

About the role

ResMed's Global Regulatory Affairs organisation is looking for a Senior Manager, Regulatory Affairs - Global Supply Chain Transformation, based in Singapore. You will shape regulatory strategies for major global operational initiatives and embed regulatory considerations into business decisions and project governance from the start. The role builds an effective Regulatory Affairs operating model, strengthens collaboration across global and regional teams and creates scalable processes, working across Regulatory Affairs, Quality, Manufacturing, Engineering and Supply Chain. It may also include direct people management and building broader Regulatory Affairs capability.

Key responsibilities

• Represent Regulatory Affairs in global Supply Chain strategic project teams, bringing regulatory insight into planning, governance and decision-making.
• Develop regulatory strategies for manufacturing changes, site transfers, new sites, sourcing and supplier changes, packaging modifications, process changes and distribution strategies.
• Lead global regulatory impact assessments and define the activities needed to support operational changes across impacted markets.
• Coordinate submissions, notifications, registrations and facility licences where applicable, ensuring consistent interpretation of global regulatory requirements.
• Integrate regulatory considerations early into project planning, identify challenges early and develop pragmatic mitigation strategies.
• Build partnerships with senior leaders across Supply Chain, Quality, Manufacturing, Engineering and Regional Regulatory Affairs.
• Establish and improve the Regulatory Affairs operating model, and develop scalable processes, playbooks and tools.
• Build a knowledge-management framework, define and monitor KPIs, and lead a global network of Regulatory Affairs subject-matter experts.
• Strengthen collaboration between Global and Regional Regulatory Affairs teams, coach regional teams and project members, and translate regulatory changes into business implications and recommendations.

Required profile

• 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 within the medical device industry.
• Experience supporting global manufacturing changes, product lifecycle management, registrations and Supply Chain or Operations projects.
• Experience managing people or leading matrix teams, and supporting global transformation initiatives.
• Experience in Supply Chain, Manufacturing or Operations.

Required skills

• Knowledge of global medical device requirements, including FDA, EU MDR, ISO 13485, Health Canada, TGA and ANVISA.
• Strong understanding of regulatory change management and global registration strategies.
• Demonstrated success leading complex cross-functional projects in global organisations.
• Clear communication, negotiation, stakeholder management, project leadership and prioritisation.
• Confidence working in a highly matrixed, multicultural and global environment.