Global Process Lead Regulatory Affairs

Ambu A/S; Ballerup Kommune; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Ambu A/S is seeking a Global Process Lead – Regulatory Affairs at our headquarters in Ballerup, Denmark. The role centers on shaping and developing regulatory processes across the product lifecycle and enabling the rollout of a new Product Lifecycle Management system.

You will collaborate with stakeholders worldwide to ensure documentation, systems, and data support regulatory requirements. The role emphasizes process ownership, audits, and strong cross-functional coordination to maintain

Qualifications

• Relevant academic degree in Life Sciences, Engineering, or similar.
• Experience with regulatory processes across product lifecycles in regulated industries.
• Experience with process ownership and development in regulated environments.

Responsibilities

• Act as Process Owner for regulatory processes across the product lifecycle.
• Support transition to a new Product Lifecycle Management system.
• Ensure processes are effective, aligned, and fit for purpose across functions.
• Identify dependencies, gaps, and drive improvements across stakeholders.
• Participate in audits and explain process governance and implementation.

Skills

Regulatory processes

Process ownership

Stakeholder management

Analytical thinking

Clear communication

Education

Relevant academic degree (Life Sciences or Engineering)

Job description

Department: Regulatory Affairs EndoIntelligence

Employment Type: Full-time

Are you passionate about regulatory processes and ensuring they work effectively across the product lifecycle?

Do you thrive in a structured, project-driven environment where your attention to detail and ability to create overview makes a real impact?

If you enjoy connecting the dots between processes, systems, documentation, and people, and occasionally asking "does this actually make sense?" you might fit right in.

We are looking for a Global Process Lead – Regulatory Affairs to join our Global Regulatory Affairs organization at our headquarters in Ballerup, Denmark.

You will become part of a collaborative and highly engaged team, working closely with stakeholders across functions and geographies. As Process Owner, you will help shape and develop regulatory processes across the product lifecycle and have real influence on how we work globally.

You will ensure that requirements, systems, documentation, and stakeholders work together in practice, not just on paper, while contributing to the implementation of a new Product Lifecycle Management system.

You will work across key Regulatory Affairs process areas, including labeling, product registration, and regulatory intelligence.

Key responsibilities

• Act as Process Owner for the relevant regulatory process and ensure that it supports regulatory requirements while remaining aligned with related processes across the product lifecycle
• Ensure that the regulatory process remains effective, connected, and fit for purpose throughout the transition to a new lifecycle management system, while identifying opportunities for improvement
• Contribute to the development and maintenance of relevant QMS documentation and ensure consistency between process requirements and operational ways of working
• Identify dependencies, resolve gaps, and ensure alignment across functions and lifecycle stages
• Work closely with SMEs, Global Process Owners, and other stakeholders to align processes, responsibilities, interfaces, and supporting data requirements
• Participate in internal and external audits as Process Owner and explain how the process is governed, implemented, and maintained
• Support workshops, training, and change management activities to ensure consistent understanding and application of the process

About you

Skills and experience can be gained in many ways, and we know the perfect profile cannot be prescribed on paper. You are, however, likely to succeed in this role if you bring many of the following:

• A relevant academic degree in Life Sciences, Engineering, or similar, along with experience working within Regulatory Affairs in a regulated industry such as medical devices or pharma
• You have a good understanding of regulatory processes and how they support products throughout the product lifecycle
• Experience with process ownership and process development in a regulated environment is a strong advantage
• Ability to shape and improve complex regulatory processes while ensuring alignment across functions and lifecycle stages
• A basic understanding of how systems support regulatory processes and data flows throughout the product lifecycle
• Strong stakeholder management skills and the ability to create alignment across functions and organizational levels
• A structured and pragmatic approach, combined with strong analytical and communication skills
• You are 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 have any questions about the position, you can contact Marianne Høy, Head of EndoIntelligence, Compliance and [e-mail].

About Ambu

Ambu has been bringing the solutions of the future to life since 1937. Today, millions of patients and healthcare professionals worldwide depend on the efficiency, safety and performance of our single-use endoscopy, anaesthesia, and patient monitoring solutions. We continuously look to the future with a commitment to deliver innovative quality products that have a positive impact on patient care and the work of healthcare professionals. Headquartered near Copenhagen in Denmark, Ambu employs approximately 4,500 people in Europe, North America and the Asia Pacific.