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. 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:
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.
Regulatory Strategy & Compliance
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.
Commercial & Customer Quality
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.
Leadership & Stakeholder Management
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.
Your qualifications and experience:
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 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.
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 vantaggi 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 embraces different perspectives, open debate, and the will to challenge convention. 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. As an equal opportunity employer, we welcome applications from individuals with disabilities.# 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 no-style=“font-family: “Siemens Sans”; 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. Siemens Healthineers Germany was awarded the Great Place to Work® certificate.

📌 DX Head of Quality Management & Regulatory Affairs, EMEA (f/m/d) (Milano)
🏢 Siemens Healthineers
📍 Milano