Senior Regulatory Affairs Specialist, Compliance and Processes

Job description

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 contrib...