DX Head of Regions Quality Management and Regulatory Affairs

Siemens Healthineers

1d•$244,000 - $335,500•Remote

About The Position

Lead the regional Quality & Regulatory Affairs organization across North America, EMEA, APAC, and Latin America, establishing a harmonized, standardized, high-performing operating model that supports regulatory compliance, product safety, and operational excellence across Commercial Operations and Customer Services. Serve as Regional Head of Quality & Regulatory Affairs for North America, ensuring compliance, product quality, and business continuity. Develop and execute regional Quality & Regulatory strategies, translating regulatory requirements into practical business actions that support market access, customer satisfaction, and sustainable growth. Act as the Quality Representative for assigned legal entities and foster a risk-based quality culture that balances regulatory compliance with business objectives. The role leads regional teams and drives consistent Quality Management Systems, regulatory execution, governance, performance measurement, and continuous improvement, while enabling appropriate regional flexibility. It also oversees quality management and regulatory compliance for North American commercial operations and customer services, including product integrity, product safety, and post-market surveillance and reporting.

Requirements

15+ years of experience in Quality and/or Regulatory Affairs within medical device or pharma, including leadership responsibility.
Strong experience with QMS, regulatory submissions and 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.
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.
Ability to work with controlled technology in accordance with US export control law.

Responsibilities

Lead and develop 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 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.
Maintain and continuously improve the Quality Management System to meet regulatory and business requirements.
Ensure effective execution of Quality Assurance and Quality Engineering processes, including audits, training, documentation, CAPA, and 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.
Use digital tools and data insights to improve quality performance, transparency, and decision-making.
Define and execute regional regulatory strategy, ensuring timely submissions and approvals and adherence to country-specific requirements.
Ensure compliance with internal policies and external regulations, with a focus on product safety and market access; translate requirements into clear business implications and guidance for leadership teams.
Serve as a key interface to health authorities and external stakeholders, representing the organization effectively.
Ensure product integrity and compliance across commercial operations and customer services.
Ensure timely and accurate Post Market Surveillance & Reporting.
Partner with customer-facing teams to resolve quality issues and improve the end-to-end customer experience.
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 with global Quality and cross-functional teams to align standards, share best practices, and ensure consistent execution.
Act as the Quality Representative for assigned legal entities.