Regulatory Affairs Manager (m/w/d)
Negotiable
Baden-Württemberg

Regulatory Affairs Manager (m/w/d) für Medizinprodukte

Für den Süddeutschen Standort sucht mein Kunde eine/n Regulatory Affairs Manager(m/w/d). In dieser Rolle sind Sie für die Recherche, Bewertung und Implementierung regulatorischer und normativer Anforderungen verantwortlich und tragen maßgeblich zur Sicherstellung der Qualität und Compliance von Produkten bei.

Ihre Aufgaben:

  • Recherche, Bewertung und Implementierung von regulatorischen und normativen Anforderungen für Medizinprodukte
  • Durchführung von GAP-Analysen sowie Erstellung und Aktualisierung von technischen Dokumentationen, Risikoanalysen und anderen relevanten Dokumenten
  • Recherche der Zulassungsvoraussetzungen und Durchführung nationaler sowie internationaler Zulassungs-, Verlängerungs- und Änderungsverfahren
  • Kommunikation mit Behörden und Distributoren im Rahmen von Zulassungsverfahren
  • Pflege des Post-Market-Surveillance-Systems zur Sicherstellung der Produktqualität im Markt
  • Unterstützung bei weiteren Themen im Bereich Qualitätsmanagement

Ihr Profil:

  • Abgeschlossenes Studium im Bereich Ingenieurwesen, Naturwissenschaften oder einer vergleichbaren Fachrichtung
  • Berufserfahrung im Bereich Regulatory Affairs, idealerweise im Medizinproduktebereich
  • Sehr gute Kenntnisse der relevanten regulatorischen Anforderungen und Normen
  • Erfahrung in der Erstellung technischer Dokumentationen sowie in der Durchführung von Zulassungsverfahren
  • Ausgezeichnete Kommunikationsfähigkeiten in Deutsch und Englisch

Bereit für den nächsten Schritt?

Wenn Sie sich auf die Möglichkeit freuen, zur globalen Entwicklung von Medizinprodukten beizutragen, freue ich mich auf Ihre Bewerbung!

Tel: 089 26 20 09 25

E-Mail: M.Inderhees@sciproglobal.de

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