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Regulatory Compliance Specialist

vor 3 Monaten

Ludwigshafen am Rhein, Rheinland-Pfalz, Deutschland ABAX GmbH Vollzeit

Regulatory Affairs Specialist (m/w/d)

Wir suchen eine/n engagierte/n Regulatory Affairs Specialist (m/w/d) für unser dynamisches Team bei ABAX GmbH. In dieser Rolle sind Sie verantwortlich für die Sicherstellung der Einhaltung aller regulatorischen Vorgaben im Zusammenhang mit unseren Produkten.

Ihre Vorteile:
  • Option auf ein Jobticket
  • Exklusiver Zugang zu dauerhaften Rabatten bei über 800 führenden Marken
  • Bonuszahlungen, einschließlich Urlaubs- und Weihnachtsgeld sowie Mitarbeiterempfehlungsprogramme
  • Überdurchschnittliche Vergütung
  • Hohe Übernahmequote von über 42%
  • Persönliche Unterstützung von der Bewerbung bis zur Übernahme
  • Individuelle Weiterbildungsmöglichkeiten
Ihre Aufgaben:
  • Erstellung, Überprüfung und Aktualisierung von regulatorischen Dokumenten für Medizinprodukte unter Berücksichtigung nationaler und internationaler Vorschriften
  • Enge Zusammenarbeit mit relevanten Behörden zur Gewährleistung einer reibungslosen Zulassung und Konformität unserer Produkte
  • Bewertung der regulatorischen Auswirkungen von Produktänderungen und Initiierung entsprechender Maßnahmen
  • Überwachung von Gesetzesänderungen und regulatorischen Entwicklungen zur proaktiven Information des Unternehmens
  • Unterstützung bei internen und externen Audits sowie Inspektionen durch Regulierungsbehörden
  • Zusammenarbeit mit anderen Abteilungen zur Sicherstellung der Erfüllung aller regulatorischen Anforderungen
Ihr Profil:
  • Abgeschlossenes Studium in Naturwissenschaften, Pharmazie, Chemie oder einem verwandten Bereich
  • Erfahrung im Bereich Regulatory Affairs, vorzugsweise in der Medizinproduktebranche
  • Fundierte Kenntnisse der nationalen und internationalen regulatorischen Anforderungen
  • Gutes Verständnis von Qualitätsmanagementsystemen (ISO 13485)
  • Starke Kommunikationsfähigkeiten und die Fähigkeit, komplexe regulatorische Anforderungen klar zu vermitteln
  • Teamfähigkeit und selbstständige Arbeitsweise
  • Gute Englischkenntnisse in Wort und Schrift

Wenn Sie sich in dieser Position wiedererkennen und eine spannende berufliche Herausforderung suchen, freuen wir uns auf Ihre aussagekräftige Bewerbung.