Regulatory Affairs Manager

vor 3 Wochen

Zug, Zug, Schweiz KMP MANAGEMENT CONSULTING Vollzeit
Aufgaben

Als Regulatory Affairs Manager sind Sie für die Einhaltung der regulatorischen Anforderungen für Medizinprodukte verantwortlich. Sie müssen sicherstellen, dass Produkte und Prozesse den neuen und existierenden regulatorischen Anforderungen entsprechen.

  • Identifizierung von anwendbaren regulatorischen, legalen und anderen externen Anforderungen in Bezug auf Medizinprodukte
  • Etablierung eines Corporate Office zur zentralen Koordination der Erstellung/Aufrechterhaltung von regulatorisch-konformen Kennzeichnungsmaterialien für Medizinprodukte
  • Beurteilung der Produkte auf deren Risikopotential
  • Unterstützung bei der Erstellung von zulassungsrelevanten Dokumenten für die weltweite Registrierung von FME Medizinprodukten
  • Planung, Dokumentation, Monitoring, Reporting und Nachverfolgung von Projekten im regulatorischen Bereich des Medizinprodukte-, Qualitätsmanagementsystems
  • Mithilfe bei der Realisierung von klinischen Bewertungen und Marktüberwachungen (post market surveillance)
  • Intensive Kommunikation mit internen Fachabteilungen, Kooperationspartnern und Zulassungsstellen weltweit
Qualifikation
  • Erfolgreich abgeschlossenes Studium im wissenschaftlichen, medizinischen oder technischen Bereich oder vergleichbare Ausbildung
  • Mehrjährige Berufserfahrung als Spezialist im Regulatory Affairs und/oder Qualtitätsmanagement vorzugsweise in branchennahen Unternehmen mit internationaler Ausrichtung
  • Sehr gute Kenntnisse der Regularien für Medizinprodukte
  • Gute analytische Fähigkeiten
  • Sicher in der Umsetzung von Moderations- und Präsentationstechniken
  • Proaktives und lösungsorientiertes Vorgehen
  • Sehr gute Deutsch- und Englischkenntnisse, jede weitere Fremdsprache ist vom Vorteil
Benefits
  • Eine interessante Aufgabe in einem innovativen, international tätigen Familienunternehmen
  • Eine Unternehmenskultur, in der es Spass macht Ideen, Kraft und Initiative einzubringen
  • Mitarbeit in einem engagierten Team
  • Flache Hierarchien und kurze Kommunikationswege
  • Überdurchschnittliche Sozialleistungen

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