Global Process Lead Regulatory Affairs

Ambu; Ballerup; On-site; DKK 900,000 - 1,200,000; Full time

Job summary

Ambu, headquartered in Ballerup, Denmark, seeks a Global Process Lead for Regulatory Affairs to shape regulatory processes across the product lifecycle. You will drive alignment with stakeholders worldwide and contribute to implementing a new Product Lifecycle Management system.

You will interact with global teams to ensure regulatory requirements are embedded in how we work, from labeling to product registration and regulatory intelligence.

Qualifications

• Regulatory Affairs experience in a regulated industry (medical devices or pharma).
• Strong understanding of regulatory processes across the product lifecycle.
• Experience with process ownership and development in regulated environments.
• Ability to shape and improve complex regulatory processes with cross-functional alignment.
• Basic understanding of systems and data flows that support regulatory processes.
• Strong stakeholder management and ability to align across functions.
• Structured, pragmatic approach with analytical and communication skills.
• Fluent in English (written and spoken).

Responsibilities

• Act as Process Owner for the relevant regulatory process and ensure it supports regulatory requirements.
• Maintain effectiveness and fit for purpose during transition to a new lifecycle management system and identify improvements.
• Develop and maintain relevant QMS documentation, ensuring consistency with process requirements.
• Identify dependencies, gaps, and alignment across functions and lifecycle stages.
• Collaborate with SMEs and Global Process Owners to align processes, interfaces, and data needs.
• Participate in audits as Process Owner and explain governance and maintenance practices.
• Support workshops, training, and change management to ensure understanding and application.

Skills

Regulatory affairs

Process ownership

Stakeholder management

Lifecycle understanding

Analytical skills

Education

Life Sciences or Engineering degree

Tools

Product Lifecycle Management (PLM) system

Job description

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

• 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].