Head of Regions Quality Management and Regulatory Affairs

Join us in pioneering breakthroughs in healthcare.

For everyone.

Everywhere.

Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality.

We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Position: Head of Regions Quality Management and Regulatory Affairs Head
Location: US East coast

Mission / Position summary:


* Lead the Regional Quality & Regulatory Affairs organization across North America, EMEA, APAC, and Latin America, driving a harmonized, standardized, and high-performing operating model that ensures regulatory compliance, product safety, and operational excellence across Commercial Operations and Customer Services.


* Serve as the Regional Head of Quality & Regulatory Affairs for North America, ensuring compliance, product quality, and business continuity across commercial operations and customer services.


* Develop and execute regional Quality & Regulatory strategies, translating regulatory requirements into pragmatic business actions that enable market access, customer satisfaction, and sustainable growth.


* Act as the Quality Representative for assigned legal entities, fostering a risk-based quality culture that balances regulatory compliance with business objectives.

Key responsibilities:

Global Regions leadership


* Lead and develop the Regional Quality & Regulatory leadership teams across EMEA, APAC, and Latin America, driving capability, accountability, and performance.


* Establish a harmonized global operating model by standardizing Quality & Regulatory processes, governance, tools, and best practices across all regions.


* Drive consistency in Quality Management Systems, regulatory execution, performance metrics, and continuous improvement while enabling appropriate regional flexibility.


* Foster cross-regional collaboration, knowledge sharing, and operational excellence to improve efficiency, compliance, and customer outcomes.

Quality Management & Continuous Improvement NAM


* Maintain and continuously improve the Quality Management System (QMS) to meet regulatory and business requirements.


* Ensure effective execution of Quality Assurance and Quality Engineering processes (e.g., audits, training, documentation, CAPA, nonconformance management).


* Identify and mitigate quality risks in commercial operations through structured risk management.


* Drive process improvements that increase efficiency, product quality, and customer satisfaction.


* Leverage digital tools and data insights to enhance quality performance, transparency, and decision-making.

Regulatory Strategy & Compliance NAM


* Define and execute the regional regulatory strategy, ensuring timely submissions, approvals, and adherence to country-specific requirements.


* Ensure full compliance with internal p...