Senior Regulatory Affairs Specialist, Compliance and Processes

Job Description

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Senior Regulatory Affairs Specialist, Compliance and Processes

City:  Ballerup

Country/Region:  Denmark

State: 

Business Area:  Regulatory Affairs

Department:  Regulatory Affairs EndoIntelligence

Employment Type:  Full-time

Req ID:  10166

Ambu A/S is currently looking for a Senior Regulatory Affairs Specialist to be based in Ballerup

In this role, you will take end‑to‑end ownership of key Regulatory Affairs (RA) processes, with a strong focus on structure, flow, and continuous improvement. You will act as a central interface towards our Notified Body and work closely with Quality, Operations, R&D and site stakeholders, while remaining firmly anchored in Regulatory Affairs.

You will join a strong and collaborative RA organization where knowledge sharing, ownership, and professional development are key values. We offer the right candidate a role with clear ownership, influence, and room to grow. This position will suit a candidate who enjoys combining process ownership, stakeholder coordination, and hands‑on regulatory work, and who is motivated by shaping and maturing regulatory processes in an international environment.

Key responsibilities

Your main responsibilities will include:

• Acting as a key Regulatory Affairs contact towards our Notified Body, including ongoing communication and participation in meetings. You will support and maintain device schedules, coordinate and manage change notifications, and contribute to audit preparation and execution from an RA perspective. This includes handling correspondence related to audits, regulatory changes, and compliance topics.
• End‑to‑end ownership and continuous optimization of the Regulatory Affairs process area, ensuring clear structure, efficient flow, and consistent application across the organization
• Identification of gaps, risks, and improvement opportunities within RA processes, including maintenance and approval of RA‑related procedures and instructions
• You will facilitate and drive Regulatory Affairs related projects, contributing with both regulatory insight and structured execution
• Ensuring correct maintenance and quality of RA‑related data in relevant systems

Suggested candidate profile

Skills and experiences can be earned in many different ways, and we understand that the best fit for the role cannot be prescribed on paper. You are however likely to succeed in this position if you:

• Hold a Master’s degree in engineering, biology, or another relevant scientific discipline (or have equivalent relevant experience)
• Have experience within Regulatory Affairs for medical devices; familiarity with MDR, ISO 13485, audits, and Notified Body interactions is an advantage
• Bring a strong process mindset and enjoy creating structure, alignment, and transparency across functions and sites
• Are confident working cross‑functionally and internationally, engaging a broad range of stakeholders
• Work in a structured and proactive manner and are comfortable taking ownership and driving topics forward
• Are fluent in English, both written and spoken;

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.

Whilst this ad might be up until the 21 May, we will invite candidates for interviews on a continuous basis so no need to hesitate.

For further inquiries please contact, Head of Regulatory Affairs Compliance and Processes, Marianne Høy, at +45 40123141.

Your application will be treated confidentially.

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. 

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.

For more information, please visit ambu.com or follow us on LinkedIn.