City: Ballerup

Country/Region: Denmark

State:

Business Area: Regulatory Affairs

Department: Regulatory Affairs EndoIntelligence

Employment Type: Full-time

Req ID: 10231

Global Process Lead UDI, Regulatory Affairs
Ambu A/S is currently looking for a Global Process Lead UDI, Regulatory Affairs, to be based in Ballerup. In this role, you will play a key part in shaping how UDI is managed across systems, data, and the product lifecycle within a global medical device company.

Anchored in Regulatory Affairs, you will take ownership of how UDI requirements are defined, implemented, and operationalized across the organization. The role sits at the intersection of regulatory requirements, data governance, system integration, and lifecycle management, with a focus on establishing robust and scalable ways of working.

In this role, you ensure that UDI requirements are effectively translated into coherent processes, high-quality data, and well-functioning system flows across the product lifecycle. You act as a key link between Regulatory Affairs, IT, and project teams, driving alignment and ensuring that UDI is consistently embedded across systems and processes.

You will join a strong and collaborative Regulatory Affairs organization where knowledge sharing, ownership, and professional development are key values, and where you are offered clear responsibility, influence, and room to grow.

Key responsibilities
Your main responsibilities will include:

• Interpret and maintain global UDI requirements (EU, US and other relevant markets) and ensure they are consistently implemented
• Own and maintain the end-to-end UDI process across systems, data, and lifecycle
• Define and maintain UDI data requirements, structures, and governance to ensure high data quality and consistency
• Ensure compliant submission of UDI data to regulatory databases such as EUDAMED and GUDID
• Drive alignment between UDI data and regulatory submissions across systems
• Act as business interface towards IT, ensuring correct requirements, implementation, testing, validation, and resolution of system-related topics
• Ensure that UDI requirements are integrated into product changes, lifecycle management, and relevant projects
• Drive continuous improvements with focus on compliance, scalability, and efficient data flows
• Support audit readiness and represent UDI processes towards auditors and notified bodies

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

• Have a relevant academic degree in Life Sciences, Engineering or similar, ideally combined with experience within Regulatory Affairs or Quality Management in a regulated industry such as medical devices or pharma
• Experience with system implementations, data migration, or structured data work is a strong advantage
• Knowledge about UDI would be considered an advantage, but is not an asbsolute prerequisite
• Ability to create structure and maintain overview in complex data and process landscapes
• Structured, analytical, and detail-oriented with a pragmatic, solution-oriented approach and strong sense of ownership
• Confident working cross-functionally and internationally, engaging a broad range of stakeholders

• Fluent in English, both written and spoken.

Ambu – a visionary and international workplace where your efforts matter
Ambu is a company that expands rapidly and has ambitious growth targets. We meet these targets through interdisciplinary teamwork between motivated and highly skilled employees. Your contributions and efforts are crucial to our success and by joining us you will get the opportunity to work in an international head office with an informal working environment.

We offer great opportunities for personal development. Furthermore, we offer a wide range of professional, social and financial employee benefits in addition to exciting job challenges and continuous professional and personal development.

When to apply
As an equal opportunity employer, all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin. If you are ready to apply for the position, please apply as soon as possible. We will invite candidates for interviews on a continuous basis so there is no need to hesitate.

If you have any questions about the position, you can contact Marianne Høy, Head of EndoIntelligence, Compliance and Processes at [email protected].