DX Head of Quality Management & Regulatory Affairs, EMEA (f/m/d)

Department: SHS DX QT-LS

Mode of Employment: Permanent / Full-time

Job Grade: Germany - Non Senior Management - PL4 - Position Level 4

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sounds interesting?

Then come and join our global team as DX Head of Quality Management & Regulatory Affairs, EMEA (f/m/d), to lead the Quality Management & Regulatory Affairs function across the EMEA region, ensuring compliance, product safety, and operational excellence across commercial operations and customer services.

You will drive and execute regional quality and regulatory strategies, translating requirements into practical business actions that enable market access, customer satisfaction, and sustainable growth.

You will serve as the Quality Representative for assigned legal entities and champion a pragmatic, risk-based approach that balances regulatory compliance with business objectives.

This position can be located at the following locations:

• Marburg (Germany)
• Milan (Italy)
• Madrid (Spain).

Quality Management & Continuous Improvement

• 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.
• Ensure inspection readiness across all markets in the region, manage external inspections and internal audits.

• Define and execute the regional regulatory strategy that supports business growth objectives, 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.

• Establish governance framework, ensuring Commercial teams, Customer Services teams and Business Partners operate in accordance with local requirements and corporate quality standards.
• 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.

• Embed a strong quality culture focused on continuous improvement and customer-centricity.
• Build and lead a high-performing and engaged 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.
• Lead interactions with local authorities to support regulatory compliance, product lifecycle activities and business continuity across the region.

• You have a university degree in life sciences, engineering, or related field.
• You have many years of experience in Quality and/or Regulatory Affairs within medical device / pharma, including leadership responsibility.
• You have very strong experience with QMS, regulatory submissions/approvals, inspections (e.g., FDA/NMPA), and product safety/compliance frameworks.
• You have a proven track record in international, matrix organizations and multi-market environments.
• You possess demonstrated leadership across multiple markets in the region.
• You have deep expertise in Quality & Regulatory frameworks, including QMS, audits, and authority interactions.
• You have the ability to translate quality and regulatory requirements into clear business actions and decisions, including effectively managing quality and compliance risks across direct and indirect markets within the region.

• You have fluent English language skills.
• You have a strong analytical, data-driven, and problem-solving mindset.
• You excel by your effective stakeholder management and communication in global, cross-functional settings.
• You have the proven ability to lead, develop, and drive performance of high-performing teams.
• You showcase high ownership, execution focus, and change agility.

Siemens Healthineers is a leading global medical technology company. 74,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services.

Our culture:

Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success. Check our Careers Site at https://www.siemens-healthineers.com/de/careers

As an equal opportunity employer, we welcome applications from individuals with disabilities.#myabilityshs

Wish to find out more before applying? Contact us: [email protected], if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is Klaus Kouril.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. Click here to get started.

To all recruitment agencies:

Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.

Siemens Healthineers Germany was awarded the Great Place to Work® certificate.