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

Lead and support crossfunctional 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. Update, and maintain technical documentation and dossiers for medical devices (Class I to III). Collaborate with quality management in risk assessments, usability analyses, and postmarket surveillance. Maintain effective communication with global regulatory authorities, international partners, and internal teams.

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