Senior Manager, Regulatory Affairs – Global Supply Chain Transformation

Worklane GmbH; Singapore; Presencial; SGD 150.000 - 230.000; Jornada completa

Descripción de la vacante

Resmed is seeking a Senior Manager, Regulatory Affairs – Global Supply Chain Transformation to shape regulatory strategies for major global initiatives and embed regulatory thinking into project governance from the start.

The role involves leading an operating model, collaborating with Regulatory Affairs, Quality, Manufacturing, Engineering and Supply Chain, and may include people management as the organisation evolves.

Formación

• Bachelor degree or higher in Life Sciences or related field.
• 8–10 years Regulatory Affairs in medical device industry.
• Experience with global manufacturing changes and submissions.

Responsabilidades

• Represent Regulatory Affairs in global Supply Chain steering committees.
• Develop regulatory strategies for manufacturing changes, site transfers and packaging modifications.
• Lead regulatory impact assessments and define activities to support operational changes.

Conocimientos

Regulatory strategy

Cross-functional leadership

Project leadership

Stakeholder management

Communication

Risk management

Educación

Bachelor's in Life Sciences or related

Regulatory Affairs RAC (preferred)

Herramientas

Regulatory submissions systems

Descripción del empleo

Shape the regulatory strategy behind global supply chain transformation.

Join Resmed’s Global Regulatory Affairs organisation as the strategic Regulatory Partner supporting Supply Chain transformation. As Senior Manager, Regulatory Affairs – Global Supply Chain Transformation, you will shape regulatory strategies for major global operational initiatives and ensure regulatory considerations are built into business decisions and project governance from the start.

This is a highly visible leadership opportunity to establish an effective Regulatory Affairs operating model, strengthen collaboration across global and regional teams, and create scalable processes that support consistent regulatory decision-making. Working across Regulatory Affairs, Quality, Manufacturing, Engineering and Supply Chain, you will help anticipate risk, protect business continuity and enable responsible execution while maintaining an unwavering focus on patient safety.

The role may also include direct people management as the organisation evolves, alongside responsibility for building broader Regulatory Affairs capability in support of global Supply Chain transformation.

This position is based in Singapore.

What You'll Do

• Represent Regulatory Affairs within 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 changes, supplier changes, packaging modifications, process changes and distribution strategies.
• Lead global regulatory impact assessments and determine the activities required 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 to support informed decisions and reduce downstream risk.
• Identify regulatory challenges before they become project risks or business escalations, and develop pragmatic mitigation strategies that balance 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 that enable 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 diverse functions and markets.
• Coach and guide regional teams and project members, contributing to organisational capability and future Regulatory Affairs talent development.
• Translate regulatory changes into clear business implications and strategic recommendations.
• Ensure compliance with applicable international regulations while enabling efficient business execution.

What You Bring

• A 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.
• 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 regulatory frameworks.
• A strong understanding of regulatory change management and global registration strategies.
• Demonstrated success leading complex cross-functional projects within global organisations.
• Strong business acumen, with the ability to evaluate risk and balance regulatory compliance with operational priorities.
• Clear communication, negotiation, stakeholder-management, project-leadership and prioritisation capabilities.
• Experience establishing governance models, operating processes and cross-functional collaboration.
• Confidence working in a highly matrixed, multicultural and global environment.
• Experience managing people or leading matrix teams.
• Experience supporting global transformation initiatives.
• Experience in Supply Chain, Manufacturing or Operations.

What Sets You Apart

• Strategic thinking: You connect regulatory priorities with the wider business context and turn complexity into clear direction.
• Trusted influence: You earn credibility, build alignment and shape decisions without relying on formal authority.
• Calm resilience: You remain considered and constructive when navigating ambiguity, competing priorities and organisational change.
• Sound judgement: You balance business objectives with regulatory risk while maintaining zero tolerance for patient risk.
• Proactive ownership: You anticipate challenges, act early and focus on practical solutions and continuous improvement.
• Collaborative leadership: You create accountability and engagement across functions, regions and professional perspectives.

Why Join Resmed

At Resmed, our work is connected by a clear purpose: helping people breathe better and live healthier, longer lives. In this role, your regulatory leadership will help shape how global Supply Chain transformation is planned and delivered, ensuring operational progress is supported by strong, consistent regulatory thinking.

You will have the opportunity to influence major global initiatives, establish new ways of working and build organisational capability with lasting impact. It is a chance to combine regulatory expertise, business partnership and leadership in work that supports healthcare, protects patients and enables responsible transformation.

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates.