Medical Device Specialist

vor 4 Wochen


Frankfurt am Main, Hessen, Deutschland curasan AG Vollzeit
Jobbeschreibung

Wir suchen einen erfahrenen Medical Device Experte/in für Substanz basierte Medizinprodukte bzw. Nicht-Aktive Medizinprodukte, der sich auf die regulatorische und dokumentatorische Unterstützung von Medizinprodukten über den gesamten Produktlebenszyklus konzentriert.

Aufgaben
  • Erarbeitung von maßgeschneiderten Lösungen und/ oder Strategien für die Zulassung von substanzbasierten Medizinprodukten gemäß der MDR 2017/745
  • Technische und regulatorische Bearbeitung von Medizinprodukten idealerweise in Kombination mit Kenntnissen der pharmazeutischen und/oder kosmetischen Formulierung
  • Erstellung der technischen Dokumentation gemäß Annex I/II/III der MDR 2017/745
Qualifikation
  • Abgeschlossene Ausbildung im Bereich Pharma- oder Medizintechnik oder vergleichbarer Ausbildungshintergrund
  • Fundierte Kenntnisse und Erfahrungen im Schreiben von Technischen Dokumentation oder auch von CTD Modul 3 und 2.3 im Rahmen von pharmazeutischen Zulassungen
  • Fundierte Kenntnisse und Erfahrung mit den regulatorischen Grundlagen, die durch die MDR (EU) 2017/745 definiert sind, insbesondere für die Regulierung von substanzbasierten Medizinprodukten
  • Erfahrung in der Medizinprodukteindustrie, vorzugsweise in Positionen in Forschung und Entwicklung, Regulatory/Scientific Affairs oder bei benannten Stellen (Notified Bodies)
  • Sehr gute Deutsch- und Englischkenntnisse in Wort und Schrift
  • Ausgezeichnete Fähigkeiten im Projektmanagement
  • Hohes Maß an Team- und Kommunikationsfähigkeit
Benefits
  • Flexible Arbeitszeiten
  • Eine inklusive Arbeitsumgebung, flache Hierarchien und offene Kommunikation
  • Eigenverantwortung und Gestaltungsspielraum
  • Eine dynamische Teamumgebung, in der Ideen ausgetauscht und gemeinsam an Projekten gearbeitet wird, um innovative Lösungen zu entwickeln
  • Regelmäßige Teamevents
  • Vergünstigte Konditionen im Fitnessstudio

Wir bieten eine spannende und herausfordernde Aufgabe in einem dynamischen Team. Wenn Sie sich für diese Position interessieren, freuen wir uns auf Ihre aussagekräftige Bewerbung mit Nennung Ihres Gehaltswunsches und frühestmöglichen Eintrittstermines.



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