Medical Device Expert
vor 4 Wochen
Wir suchen einen erfahrenen Medical Device Experten, 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
- 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
- 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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Medical Device Sales Engineer
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Medical Device Sales Engineer
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Medical Device Development Specialist
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Medical Device Specialist
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Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH VollzeitJoin Merz Aesthetics GmbH as a Working Student Filler and Medical Device DevelopmentMerz Aesthetics is a leading international company in the field of aesthetic medicine, renowned for its high-quality products and commitment to excellence. As a working student in our Filler and Medical Device Development team, you will play a vital role in supporting our...
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vor 3 Wochen
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Regulatory Affairs Manager Medical Devices EU
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Regulatory Affairs Manager Medical Devices EU
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH VollzeitAbout the PositionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Merz Aesthetics GmbH. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with EU regulations for medical devices.Key ResponsibilitiesPrepare and submit applications for conformity assessment and clinical...
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Regulatory Affairs Manager Medical Devices EU
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH VollzeitAbout the PositionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Merz Aesthetics GmbH. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with EU regulations for medical devices.Key ResponsibilitiesPrepare and submit applications for conformity assessment and clinical...
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Regulatory Affairs Manager Medical Devices EU
vor 3 Wochen
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