Head of Vigilance & Safety (m/w/d)
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Über Heraeus Medical
Wieder mobil werden bei schwerer Arthrose oder Knochenerkrankungen? Operationsergebnisse mit Knochenzement verbessern? Heraeus Medical bietet fortschrittliche Lösungen von der Orthopädie bis zum Infektionsmanagement. Exzellente Qualität treibt uns an und bringt Freude zurück – ins Leben von Patienten und in Ihren Job.
Was haben Sie vor? Spielen Sie bei Heraeus Medical in der Top-Liga der Medizintechnik!
Heraeus Medical mit Sitz in Wehrheim (Deutschland) ist eine Operating Company der Heraeus Gruppe. Diese liefert in den Bereichen Precious Metals, Healthcare, Semiconductor & Electronics und Industrials Qualität auf Weltklasseniveau. Als eines der Top-10-Familienunternehmen in Deutschland beschäftigt Heraeus rund 15.100 Mitarbeitende in 40 Ländern.
Das können Sie bewegen
- Mit Ihrer Arbeit stärken Sie die Sicherheit von Medizinprodukten über ihren gesamten Lebenszyklus. Sie steuern das globale Vigilanzsystem für Medizinprodukte bis einschließlich Klasse III und tragen dazu bei, dass „Life is for living“ auf sicheren und verlässlichen Produkten aufbauen kann.
- Von der medizinischen Bewertung von Beschwerden und unerwünschten Ereignissen bis zur Entscheidung über deren Meldepflicht: Sie beurteilen eingehende Fälle nach globalen regulatorischen Vorgaben und Fristen.
- Sie erstellen und koordinieren Sicherheitsberichte und zugehörige Dokumente, darunter PSURs, PMS-Berichte, Fallberichte, Trendanalysen und Stellungnahmen für interne und externe Anfragen – auch gegenüber Behörden.
- Bei CAPA- und FSCA-Maßnahmen sowie bei der Erstellung von Field Safety Notices (FSN) bringen Sie Ihre Expertise ein. Außerdem wirken Sie an Risikoanalysen, Produkt- und QMS-Änderungen sowie der Bewertung von Qualitätsabweichungen mit.
- Sie bewerten globale regulatorische Anforderungen und integrieren Änderungen in das bestehende Vigilanzsystem. Zudem entwickeln und pflegen Sie relevante gelenkte Dokumente und Prozesse und vertreten den Bereich bei Audits durch Benannte Stellen und internationalen Behörden sowie bei Inspektionen.
Das bringen Sie mit
- Abgeschlossenes Studium der Humanmedizin oder eines Life-Science-Fachs; Promotion oder vergleichbare Qualifikation von Vorteil
- Langjährige Erfahrung in Vigilanz oder Pharmakovigilanz, idealerweise in MedTech, Pharma oder einer CRO
- Umfassende Erfahrung mit beschleunigten und periodischen Sicherheitsdaten, zugehörigen Berichten und Stellungnahmen sowie im direkten Austausch mit internationalen Behörden
- Mindestens drei Jahre Führungserfahrung; mehrjährige praktische Erfahrung in der Orthopädie wünschenswert
- Verhandlungssicheres Deutsch und Englisch; weitere Sprachen von Vorteil
- Kenntnisse in GMP, GDP, DIN EN ISO 13485, FDA Quality System Regulation, MDSAP und MDR
- Anwenderkenntnisse in MS Office, Datenbanken, MasterControl und SAP (Magellan)
Worauf Sie sich bei Heraeus Medical freuen können:
- Spannende Aufgaben – setzen Sie diese mit hoher Eigenverantwortung in einem ambitionierten Umfeld mit sehr guten Weiterentwicklungsmöglichkeiten um
- Starkes Gehaltspaket - attraktives Grundgehalt zzgl. Bonus und Förderung der privaten Altersversorgung
- Finanzielle Zusatzleistungen - Förderung der privaten Altersvorsorge, Lebensphasenkonto für bezahlte Freistellungen (z.B. Sabbatical, früherer Eintritt in den Ruhestand), Rabatte in vielen (Online-)Shops, Fahrradleasing
- Moderne Arbeitszeitgestaltung – Zeitsouveränität (vertragliche Arbeitszeit 42,5 Wochenstunden), Fokus auf ergebnisorientiertem Arbeiten, wöchentlich 1-2 Tage mobiles Arbeiten
- Regelmäßige Auszeiten - 30 Tage Jahresurlaub plus bis zu 6 zusätzliche, freie Tage (Betriebsschließung an Brückentagen und zwischen den Jahren), Sonderurlaub für besondere Anlässe
- Gesundheit & Wohlbefinden - betriebsärztlicher Dienst mit umfassenden Vorsorgeuntersuchungen, Sozialberatung und hauseigene Mitarbeiterkantine mit täglich frisch zubereiteten Speisen
- Nachhaltigkeit und soziales Engagement - Nachhaltigkeit als Teil der Unternehmensstrategie und gezielte Förderung von Initiativen aus den Bereichen Bildung, Familie und Wissenschaft durch eigene Stiftungen
ReqID: 60179
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Global Tech & Innovation at Heraeus
Learn more about Heraeus, a global leader in precious metals, materials and technology. Discover our history, values, innovation and worldwide careers.
