Regulatory Affairs Specialist (m/f/d) - Medical Devices (Full-time)

We are seeking an experienced and proactive Regulatory Affairs Specialist to join our international team and strengthen our global regulatory and quality management activities. In this role, you will be responsible for driving regulatory strategies and submissions not only in Europe (MDR) and the U.S. (FDA), but also across diverse international markets. By ensuring compliance with global requirements and aligning closely with our quality management system, you will directly contribute to Nexpring’s to advance fertility care by ensuring our products meet highest quality standards and global regulatory requirements. The position is based at our German subsidiary near Lübeck. Regulatory Affairs Specialist (m/f/d) – Medical Devices (Full-time) Your tasks Lead and support cross-functional projects in regulatory affairs and quality management. Identify, interpret, and implement regulatory requirements across global markets, with a strong focus on international registrations outside the U.S. and EU. Independently prepare submissions and change notifications for competent authorities and international agencies.
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