DX Head of Regions Quality Management and Regulatory Affairs

About this role

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: DX 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 policies and external regulations, with a strong focus on product safety and market access. Translate regulatory requirements into clear business implications and actionable guidance for leadership teams • Act as key interface to health authorities and external stakeholders, representing the organization with credibility and impact.

Commercial & Customer Quality NAM • Ensure product integrity and compliance across commercial operations and customer services. • Ensure on time and accurate Post Market Surveillance & Reporting • Partner with customer-facing teams to resolve quality issues and improve the end-to-end customer experience.

Leadership & Stakeholder Management • Embed a strong quality culture focused on continuous improvement and customer-centricity. • Build and lead a high-performing regional Quality & Regulatory team, driving accountability, capability, and ownership. • Collaborate closely with global Quality and cross-functional teams to align standards, share best practices, and ensure consistent execution.

Your qualifications and experience: • 15+ years in Quality and/or Regulatory Affairs within medical device / pharma, including leadership responsibility. • Strong experience with QMS, regulatory submissions/approvals, inspections (e.g., FDA/NMPA), and product safety/compliance frameworks. • Proven success leading Quality & Regulatory organizations in complex, international matrix environments. • Experience driving global process harmonization, standardization, and implementation of Quality Management Systems across multiple countries and cultures. • Degree in Life Sciences, Engineering, or a related discipline.

Competency Requirements: • Deep expertise in Quality & Regulatory frameworks, including QMS, audits, and authority interactions. • Ability to translate regulatory requirements into clear business actions and decisions. • Strong analytical, data-driven, and problem-solving mindset. • Effective stakeholder management and communication in global, cross-functional settings. • Proven ability to lead, develop, and drive performance of high-performing teams. • High ownership, execution focus, and change agility. • Fluent in English.

#LI-ES1 #LI-REMOTE

Who we are : We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work: When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healt

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