Head of Regulatory Affairs Product-Lifecycle

Are you ready to take regulatory ownership of diagnostics released products on a global scale? Do you thrive in complex regulatory environments where sound judgement, global frameworks and business impact go hand in hand? Would you like to play a key role in ensuring continuous compliance for Medical Devices throughout the entire lifecycle? If so, the position as Head of Regulatory Affairs, Product-Lifecycle may be an exciting career opportunity for you.

Join a global hearing healthcare organisation

You will join Demant Diagnostics, part of a global hearing healthcare group delivering premium diagnostic solutions to hearing clinics and hospitals around the world. We are looking for an experienced regulatory leader who will take end‑to‑end responsibility for regulatory affairs across the full product lifecycle, ensuring that products placed on the market remain compliant, safe and sustainable in a dynamic regulatory landscape.

The position reports to Flemming Vinding, Vice President, Global Quality & Regulatory, and can be based at our Diagnostics sites in Middelfart, Stettin, Berlin or Padova. 

End‑to‑end regulatory responsibility across the product lifecycle

As Head of Regulatory Affairs Product-Lifecycle, you carry the end‑to‑end regulatory responsibility for all Diagnostics products. You ensure that design changes, product updates and lifecycle activities are evaluated and implemented in full compliance with applicable regulatory requirements, including ISO 13485, MDR, FDA and relevant national legislation.

You provide strategic oversight and guidance on regulatory impact, risk and business implications of proposed changes, enabling informed decision‑making and continuous compliance throughout the product lifecycle.

Where your regulatory leadership creates lasting impact

In this role, you act as the central regulatory authority for in‑market products and lifecycle activities. You work closely with Regulatory Affairs Development, Quality, Product Management and other key stakeholders across multiple sites, ensuring clear ownership, robust decision‑making and timely regulatory execution.

Main tasks & responsibilities:

• Responsible for reviewing and approving the technical documentation summary provided by Regulatory Affairs Development at handover before release for sales (part of gate sign-off)
• Evaluate and communicate the regulatory impact of proposed design changes, including documentation, submission requirements, and timelines.
• Accountable for compliance towards MDR and FDA regulations
• Responsible for the end-to-end product registration process for Diagnostics products and solutions to ensure timely governmental approval of all markets and countries and for all technologies
• Responsible for the clinical evaluation process (during development projects and post-market activities)
• Responsible for developing and maintaining regulatory intelligence, evaluating and interpreting new and revised legislation and standards, and sufficient handover to the functions accountable for implementation
• Managing a team that consists both of specialists and managers across sites and brands.

An experienced leader with a global regulatory perspective

We are looking for a confident regulatory leader with strong judgement and deep understanding of global regulatory frameworks. You are comfortable operating in complex, international organisations and balancing regulatory rigour with business needs. You have experience leading or influencing at a distance and know how to create clarity, alignment and trust in a global setup.

We imagine that you:

• Bring leadership experience from a global organisation with multiple stakeholders and geographically distributed teams
• Have a proven track record of working with regulatory affairs within the medical device industry
• Possess a deep understanding of ISO 13485, MDR, FDA regulations and global regulatory frameworks
• Are skilled in assessing regulatory risk and translating regulatory requirements into clear business implications
• Demonstrate strong analytical skills and a structured approach to documentation and compliance
• Have experience with product lifecycle management and design change control processes
• Excellent communications skills and fluency in English, both written and verbal

Want to join the team?

Then send your application, including CV in English as soon as possible. The application deadline is 10 May 2026.

• 1st Interviews will be conducted from the 12 May.
• 2nd Interviews will be conducted from the 26 May.

We are looking forward to hearing from you!

About Demant Diagnostics

Demant’s diagnostics business is a trusted diagnostic solutions provider in the field of hearing and balance assessment. This group of international companies develops, manufactures, and markets a wide variety of technological solutions globally, delivering instruments, software, training, and services that support the entire diagnostic journey – from early screening to advanced clinical assessment and balance treatment. Our portfolio includes well-known brands such as Maico, Interacoustics, Amplivox, GSI Grason-Stadler, MedRx, Audioscan, and Inventis.

Our products are sold in more than 100 countries through an extensive network of sales companies and distributors. 

For more information, please visit: www.demant.com

We value diversity, equity, and inclusion (DE&I) and we are committed to creating an inclusive working environment. We welcome applications from all qualified candidates regardless of ethnic background, personality, age, gender, and education. Diversity is part of our cultural DNA. Women in STEM areas are particularly encouraged to apply, as Demant supports United Nations Sustainable Development Goal 5 on gender equality.

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