Senior Quality Management Specialist, Global QM Sales & Distribution

Do you have strong expertise in quality and audits within a regulated medical device environment?

 

Are you motivated by acting as a strategic compliance partner to a global sales organization, supporting subsidiaries in being audit‑ready through prevention rather than reaction?

 

If so, this position as Senior Quality Management Specialist, Global QM Sales & Distribution at Ambu A/S may be your next career step.

 

A senior specialist role with strategic impact

We are looking for an experienced Quality Management specialist who will play a key role in strengthening compliance and audit readiness across Ambu’s global Sales & Distribution organization.

 

You will work closely with the Head of Global Quality Management System, Sales & Distribution and alongside other specialists in the team, acting as a trusted advisor to subsidiaries (STs) and global stakeholders. Your focus will be on preventive compliance, risk‑based assessments, and audit preparation of commercial functions, ensuring regulatory precision and avoiding unnecessary documentation.

 

This is a senior expert role with broad influence, but no people management responsibility.

 

Your key responsibilities

In this role, you will act as a strategic and preventive compliance partner by:

 

• Performing risk‑based compliance assessments of commercial functions (sales and distribution) to identify gaps well ahead of audits
• Leading audit readiness initiatives for subsidiaries, including defining audit approach and developing storyboards and guidance material
• Advising subsidiaries on regulatory priorities, focusing on what matters from a compliance and audit perspective
• Supporting subsidiaries in sub‑distributor compliance oversight, including controls, documentation, and follow‑up
• Acting as a senior sparring partner to global and local stakeholders across Global QM, Global RA and Global Sales
• Supporting inspections and audits by presenting documentation and compliance approaches within your area of responsibility

 

Your profile

You are an experienced quality professional who combines regulatory insight with strong business understanding. You are comfortable challenging constructively, advising senior stakeholders, and translating complex regulatory requirements into practical, value‑adding solutions.

 

To succeed in this role, you are likely to have:

• 6+ years of experience in Quality Management within medical devices or IVD
• Proven experience conducting or leading audits of commercial functions (ISO 13485, MDR, MDSAP)
• Solid understanding of EU MDR and FDA requirements
• Strong stakeholder management skills and ability to influence without authority in a global environment
• An analytical and risk‑based mindset with a pragmatic approach to compliance

 

Personally, you are confident, collaborative, and motivated by enabling compliance through prevention, clarity, and strong partnerships rather than control.

 

Why join Ambu?

You will join a newly established team in the global quality function, focusing on sales entities, with high visibility and impact, where your expertise will directly influence how compliance is embedded into Ambu’s commercial operating model worldwide.

 

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.