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.