Join our Global Regulatory Affairs organization as the strategic Regulatory Partner supporting Supply Chain transformation. In this highly visible leadership role, you will shape regulatory strategies for global operational initiatives, influence business decisions, build governance and operating models, and lead cross-functional collaboration across Regulatory Affairs, Quality, Manufacturing and Supply Chain. This position offers a unique opportunity to combine regulatory expertise, business partnership and organizational leadership while helping transform the way Regulatory Affairs supports global Supply Chain operations.

1. Role Overview

This position serves as the strategic Regulatory Affairs Partner for Global Supply Chain transformation initiatives. As Manager, Regulatory Affairs - Global Supply Chain Transformation, you will lead the regulatory strategy supporting major operational changes, ensuring regulatory considerations are integrated early into business decisions and project governance.

You will represent Global Regulatory Affairs across multiple global Supply Chain programs and provide strategic & operational inputs to cross-functional teams.

Beyond supporting individual projects, in close collaboration with QA, this role is responsible for establishing and continuously improving the Regulatory Affairs operating model supporting Supply Chain initiatives. This includes defining governance, strengthening collaboration between Global and Regional RA teams, developing scalable processes and knowledge management, and ensuring consistent regulatory decision-making across the organization.

The role requires strong leadership through influence, close partnership with senior Supply Chain leaders, and the ability to anticipate regulatory challenges before they become project risks or business escalations.

As the organization grows, this position may also include direct people management responsibilities while continuing to build Regulatory Affairs capability supporting Supply Chain transformation.

During the initial phase of the role, the successful candidate will work in close partnership with the VP Global Regulatory Affairs to establish the operating model, strengthen strategic partnerships with Supply Chain leadership, and build the long-term Regulatory Affairs capability supporting global Supply Chain transformation.

2. Key Responsibilities

• Represent Regulatory Affairs within global Supply Chain strategic project teams.
• Develop regulatory strategies supporting manufacturing changes, site transfers, sourcing changes, distribution changes and broader Supply Chain transformation initiatives.
• Ensure regulatory considerations are integrated early into project planning to enable informed business decisions and minimize downstream regulatory risks.
• Build trusted partnerships with senior leaders across Supply Chain, Quality, Manufacturing, Engineering and Regional Regulatory Affairs.
• Lead global regulatory impact assessments for Supply Chain initiatives.
• Drive regulatory planning for manufacturing changes, new sites, process changes, packaging modifications, supplier changes and distribution strategies.
• Coordinate global regulatory activities required to support operational changes, including submissions, notifications, registrations and facility licenses where applicable.
• Ensure consistent interpretation and application of global regulatory requirements across impacted markets.
• Identify regulatory risks early and develop pragmatic mitigation strategies balancing compliance and business continuity.
• Establish and continuously improve the Regulatory Affairs operating model supporting Supply Chain projects.
• Develop scalable processes, playbooks and tools supporting efficient execution of Supply Chain regulatory activities.
• Build and maintain an effective knowledge management framework for Supply Chain Regulatory Affairs.
• Define and monitor KPIs supporting visibility, prioritization and execution of regulatory activities.
• Lead and coordinate the global network of Regulatory Affairs SMEs supporting Supply Chain initiatives.
• Provide coaching, guidance and regulatory leadership to regional RA teams and project members.
• Contribute to organizational capability building and support the development of future Regulatory Affairs talent.
• May include direct management of Regulatory Affairs professionals as the organization evolves.
• Translate regulatory changes into business implications and strategic recommendations.
• Ensure compliance with applicable international regulations while enabling efficient business execution.

3. Profile & Qualifications

• Bachelor's degree or higher in Life Sciences, Biomedical Engineering, Pharmacy, Regulatory Affairs or a related discipline.
• Minimum 8-10 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.
• Demonstrated success leading complex cross-functional projects within global organizations.
• Previous experience influencing senior stakeholders and leading through influence.
• Experience managing people or leading matrix teams is highly desirable.
• Experience supporting global transformation initiatives is considered a strong advantage.

• Knowledge of global medical device regulations (FDA, EU MDR, ISO 13485, Health Canada, TGA, ANVISA and other major regulatory frameworks).
• Excellent understanding of regulatory change management and global registration strategies.
• Strong business acumen with the ability to balance regulatory compliance and operational priorities.
• Ability to anticipate issues, evaluate risks and develop pragmatic solutions.
• Excellent communication, negotiation and stakeholder management skills.
• Proven ability to influence decision-making at multiple organizational levels.
• Experience establishing governance models, operating processes and cross-functional collaboration.
• Comfortable working in a highly matrixed, multicultural and global environment.
• Strong project leadership and prioritization capabilities.
• Experience in Supply Chain, Manufacturing or Operations is highly desirable.

4. Behavioral Competencies / Leadership Attributes

• Strategic thinker with strong business acumen.
• Trusted advisor able to influence without formal authority.
• Collaborative leader who builds strong partnerships across functions and regions.
• Calm and resilient when navigating ambiguity and organizational change.
• Strong judgment with the ability to balance business objectives and regulatory risk.
• Proactive, solution-oriented and focused on continuous improvement.
• High ethical standards with zero tolerance for patient risk.
• Creates alignment, accountability and engagement across diverse teams.
• Passionate about developing people, building organizational capability and fostering collaboration.

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. If this sounds like the workplace for you, apply now! We commit to respond to every applicant.