On behalf of our client, a worldwide leading manufacturer of medical devices, we are seeking the Head of Regulatory Affairs. In this role, you will join a team of regulatory experts and lead the development and improvement of the regulatory affairs capabilities globally. This dedicated group manages the global regulatory strategy, handling end-to-end deliverables and submissions for new product launches, regulatory approval maintenance, and product modifications. Their responsibilities involve engaging with regulatory authorities, primarily in the EU, while maintaining connections with regulatory counterparts globally. Joining this team means becoming a part of the global management team, collaborating with leaders covering diverse business areas and strategic geographies.

Responsibilities  

Reporting to the VP of Global Regulatory Affairs, your role will be pivotal in fortifying the innovation and growth agenda of your business segment and in providing strategic guidance regarding the impact of regulatory issues on corporate strategy and operations for the regions.

Your responsibilities include defining and implementing regulatory priorities aligned with the company’s goals. This involves fostering a diverse and inclusive culture of regulatory compliance, enhancing the team's skills and capacity, managing the budget, utilizing regulatory systems, and disseminating best practices within the broader Regulatory Affairs function.

You will play a critical role by providing input on regulatory risks and opportunities for decision-making, fostering solid cross-functional partnerships with key stakeholders, and acting as the domain expert. Staying abreast of emerging regulatory knowledge, offering guidance during strategy development, and representing the company when interacting with regulatory bodies.

As a regulatory leader, you prioritize team development and motivation while driving continuous improvement in work processes for efficiency and scalability. Operating within a matrix organization in the Global Quality, Regulatory, and Sustainability department, you recognize the importance of being a key partner to various functions globally (e.g., Operations, R&D, Medical Affairs, Commercial, and Marketing) and building strong alliances as a regulatory affairs ambassador.

Experience & Education

To excel in this role, you have:

• minimum ten years of directly related professional regulatory experience and CE-marking of medical devices, particularly with Class III devices,
• a degree in regulatory science, life science, biomedical engineering, or any other relevant scientific or legal field,
• a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) or equivalent,
• prior managerial experience and fluency in English are also essential qualifications.

This role is office-based in Denmark and the successful candidate is required to be open to relocation.