Senior Project Manager, Compliance

Are you an experienced Senior Project Manager with a global mindset and a strong foundation in regulatory compliance? Do you thrive on driving cross-functional initiatives and navigating the complexities of medical device development and lifecycle management?

Then this may be your defining moment. Join us on our journey #ForeverForward and help shape the future of healthcare technology.

At Ambu, we are dedicated to creating innovative solutions that make a real difference in people’s lives. We are currently looking for a Senior Project Manager, Compliance to join our Regulatory Affairs – Compliance, Labelling & Processes team.

About The Role

As Senior Project Manager, you will lead strategic regulatory compliance initiatives, ensuring Ambu’s products and processes meet evolving global regulatory standards. You will work across regions and functions to implement high-impact compliance programs—from concept through to execution and integration. You will join an international team of 12 colleagues and report directly to the Head of Regulatory Compliance, Labelling & Processes. The team is based in both Penang, Malaysia and Ballerup, Denmark.

Key Responsibilities

• Leading large-scale, cross-functional compliance projects anchored in R&D RA and in collaboration with QA, Operations and Commercial teams as well as international stakeholders in and outside Ambu sites globally
• Coordinate with internal and external stakeholders to ensure successful implementation of new regulatory requirements (e.g., MDR, FDA, ISO standards)
• Identify potential risks, propose mitigation strategies, and regularly report on progress to senior leadership
• Embed compliance processes, procedures, and standards across the organization
• Drive governance and reporting related to the compliance project portfolio
  
  

Suggested candidate profile

We Recognize That Great Talent Comes In Many Forms. While No Single Path Defines Success, We Believe The Ideal Candidate May Bring

• A relevant academic background (e.g., engineering, life sciences, pharmacy or similar)
• 5 years of experience in project or program management, preferably within Medical Devices or Pharma
• In-depth understanding of regulatory compliance frameworks (e.g., MDR, FDA, ISO 13485)
• A collaborative approach and experience working in a global, cross-functional environment
• Strong communication skills in English—both written and spoken
  
  

Why join Ambu?

At Ambu, we foster a culture where everyone is encouraged to contribute, learn, and grow. We are committed to building an inclusive environment that values diverse perspectives and lived experiences. Your individuality helps drive our collective success.

Ready to shape what’s next in healthcare?

We encourage all qualified individuals to apply, regardless of background, identity, or lived experience.

Apply today and take your next step with us—#ForeverForward.

 

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.