GYNEMED GmbH & Co. KG

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

Stellenbeschreibung:

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

  • Typ:

    Vollzeit
  • Arbeitsmodell:

    Vor Ort
  • Kategorie:

  • Erfahrung:

    2+ years
  • Arbeitsverhältnis:

    Angestellt
  • Veröffentlichungsdatum:

    27 Nov 2025
  • Standort:

    Sierksdorf

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