Global Process Lead Regulatory Affairs

City: Ballerup

Country/Region: Denmark

State

Business Area: R&D

Department: Regulatory Affairs EndoIntelligence

Employment Type: Full-time

Req ID: 10556

• Are you passionate about regulatory processes and ensuring they work effectively across the product lifecycle? If you have any questions about the position, you can contact Marianne Høy, Head of EndoIntelligence, Compliance and Processes at [email protected].

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.

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.

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.

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

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

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

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 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.

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

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.

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