Regulatory Affairs Specialist - Device

Are you passionate about regulatory strategy for medical devices and drug-device combination products within a leading international organisation?  Do you want to play a key role in shaping global regulatory pathways for medicines addressing high unmet medical needs? If so, this could be your next life‑changing career move at Novo Nordisk. 

Your new role 

As a Regulatory Affairs Specialist, you will support selected projects and products in the Novo Nordisk portfolio, with a strong focus on drug device combination product development across global markets. Acting as the voice of Regulatory Affairs Device, you will provide strategic and scientific input to support development, secure regulatory approvals, and ensure compliance with evolving global regulations. 

You will work closely with cross-functional stakeholders and take a leading role in critical regulatory activities from development through health authority interactions and up to submission and life-cycle management. 

In this role, you will: 

• Lead and drive strategic regulatory device activities for drug-device combination products to ensure timely approvals and compliance. 

• Provide regulatory leadership in critical development projects and represent RA Device in cross-functional project teams. 

• Define and maintain global regulatory strategies for drug device combination products across development phases. 

• Plan, prepare, and lead health authority interactions and meetings, including briefing packages, meeting preparation, and follow-up activities. 

• Identify regulatory risks and opportunities, and provide clear recommendations to support project decisions. 

• Build strong partnerships with internal stakeholders and support knowledge sharing across the organisation. 

Your new department 

You will join Regulatory Affairs CMC & Device, a global organization of more than 200 dedicated professionals working across multiple regions. The department plays a critical role in making medicines available worldwide by ensuring efficient, high quality regulatory submissions and approvals. As Novo Nordisk continues to expand its portfolio, the team develops regulatory strategies for increasingly complex and innovative drug device combination product solutions. 

The position is based in Søborg, Denmark offering exposure to global projects and close collaboration across cultures and time zones. 

Your skills and qualifications 

You bring a strong scientific and technical foundation, combined with deep regulatory or pharmaceutical operations experience. 

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

• A Master’s degree and/or PhD in a relevant scientific field 

• Extensive experience from the pharmaceutical industry and/or a health authority 

• Minimum 8 years of experience within Regulatory Affairs, with at least 5 years focused on Drug–Device Combination Products. 

• Strong project management skills and the ability to navigate complex stakeholder landscapes 

• Excellent English communication skills, both written and spoken, and the ability to work effectively in multidisciplinary, international teams 

You are recognised for your proactive, can do mindset and your ability to thrive in uncertainty, helping teams find clear paths forward while acting as a professional role model.  

Working at Novo Nordisk 

Every day we seek the solutions that defeat serious chronic diseases. To do this, we approach our work with determination, constant curiosity and a commitment to finding better ways forward. For over 100 years, this dedication has driven us to build a company focused on lasting change for long-term health. One where diverse thinking, shared purpose and mutual respect come together to create extraordinary results. When you join us, you're not just starting a job – you're becoming part of a story that spans generations. 

What we offer 

There is, of course, more on offer here than the uniqueness of our culture and the extraordinary results we produce. Being part of a global healthcare company means opportunities to learn and develop are all around us, while our benefits are designed with your career and life stage in mind. 

Salary: For this role, the Annual Base Salary for employee based in Denmark ranges from 742,600 to 1,091,600 DKK, corresponding to the level of the position. 

The placement within the salary range will be assessed during the recruitment process based on the candidate’s skills, competencies, knowledge, and relevant experience.