Regulatory Affairs Consultant

vor 1 Monat

Leipzig, Sachsen, Deutschland ANGEHEUERT Recruiting Vollzeit
Aufgaben

Als Regulatory Affairs Consultant bist du verantwortlich für die Beratung und Unterstützung von Kunden in der Medizintechnik-Branche. Du unterstützt Kunden bei der Umsetzung von Regulatory Affairs-Projekten und bist für die Koordination und Durchführung regulatorischer Aktivitäten verantwortlich.

Deine Aufgaben umfassen:

  • Consulting von Kunden in der Medizintechnik-Branche
  • Planung, Bewertung und Bearbeitung von behördlichen Zulassungen für medizinische Produkte
  • Koordination und Durchführung regulatorischer Aktivitäten für Medizinprodukte
  • Entwicklung und Implementierung von regulatorischen Strategien
  • Steuerung und Koordination von technischen Dokumentationen für die internationale Zulassung von Medizinprodukten
  • Erstellung und Einhaltung von Zulassungsplänen
  • Prüfung und Bewertung zulassungsrelevanter Produktänderungen
  • Mitarbeit bei dem Risikomanagement für Medizinprodukte
Qualifikation
  • Naturwissenschaftliches oder technisches Studium mit Medizintechnik-Fokus oder vergleichbare Qualifikation
  • Mind. 2 Jahre Erfahrung in der Zulassung von medizinischen Produkten
  • Fundierte Kenntnisse der globalen Anforderungen, insbesondere der EU-MDR, der FDA-Richtlinien und des MDSAP-Programms
  • Wünschenswert: Kenntnisse von (klinischen) Studien, Risikobewertungen und Biokompatibilität
  • Erfahrungen mit QM-Prozessen (z.B. ISO 13485 und / oder ISO 14971)
  • Sehr gute Deutsch- und Englischkenntnisse
Benefits
  • Flexibles Arbeitszeitmodell mit 90% Homeoffice-Option
  • Monatsgehalt ab 5.000€ brutto
  • Weiterbildungsmöglichkeiten
  • Top-Notch-Equipment
  • Teamspirit und Firmenfeiern
  • Beste Karrierechancen
  • Blumenstrauß an Benefits

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