[Hiring] DX Head of Regions Quality Management and Regulatory Affairs @Siemens Healthineers

Role Description

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.

Qualifications

• 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.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) retirement plan
• Life insurance
• Long-term and short-term disability insurance
• Paid parking/public transportation
• Paid time off
• Paid sick and safe time