Biological Safety Expert R&D (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 Metals & Recycling, Healthcare, Semiconductor & Electronics und Industrials Qualität auf Weltklasseniveau. Als eines der Top-10-Familienunternehmen in Deutschland beschäftigt Heraeus rund 15.200 Mitarbeitende in 40 Ländern.
Haupttätigkeitsfelder
- Sie bringen Freude zurück in das Leben von Patienten - denn Ihre Arbeit ermöglicht es, innovative Medizinprodukte sicher und wirksam auf den Markt zu bringen. In der Schlüsselrolle als Biological Safety Expert R&D (m/w/d) leisten Sie einen entscheidenden Beitrag zur Entwicklung von Medizinprodukten im orthopädischen Bereich.
- Die biologische Sicherheit unserer Innovationen verantworten Sie über den gesamten Entwicklungszyklus hinweg – von der Planung über die Umsetzung bis hin zur Bewertung und Zulassung.
- Im Rahmen von Neuentwicklungen koordinieren Sie sämtliche Biokompatibilitätsaktivitäten, erstellen präklinische Arbeitspakete und behalten Termine, Budget und regulatorische Anforderungen im Blick.
- Die Zusammenarbeit mit externen Laboren gehört ebenfalls zu Ihrem Alltag: Hier steuern Sie präklinische Biokompatibilitätsstudien und stehen als interne Ansprechperson für alle Fragen rund um präklinische Testverfahren zur Verfügung.
- Sie unterstützen bei der Marktzulassung, insbesondere durch die Erstellung von Zulassungsdokumenten (z.B. toxikologische Bewertung).
- Als Biological Safety Expert R&D fungieren Sie intern als zentrale Ansprechperson für alle biologisch-wissenschaftlichen Fragestellungen in der Abteilung für Produktneuentwicklung.
Erforderliche Qualifikationen
- Erfolgreich abgeschlossenes naturwissenschaftliches Studium, idealerweise mit Promotion
- Erste Berufserfahrung im Bereich Biokompatibilität von Medizinprodukten, bevorzugt in Orthopädie und/oder Kombinationsprodukten sowie Verständnis für relevante Prüf- und Laborabläufe
- Idealerweise abgeschlossene Weiterbildung in Toxikologie oder biologischer Sicherheit von Medizinprodukten
- Fundierte Erfahrung in der Bereitstellung wissenschaftlicher Inhalte, wissenschaftlichen Forschungsmethoden und im Medical Writing
- Fundierte Erfahrung in präklinischen Testverfahren (in vitro, in vivo, ex vivo)
- Kenntnisse relevanter Gesetze und Richtlinien wie MDR 2017/745, 21 CFR 820, ISO 10993-1 sowie weiterer normativer Anforderungen zur biologischen Sicherheit
- Strukturierte, analytische und lösungsorientierte Arbeitsweise sowie ausgeprägte Teamfähigkeit und sehr gutes Zeitmanagement
- Verhandlungssichere Deutsch- und Englischkenntnisse sowie routinierter Umgang mit gängigen Softwareanwendungen
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: 58729
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