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Open nowPosted 6 days ago

Verification & Compliance Specialist

job-room.ch86,007 open roles

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Rotkreuz, ZG, Switzerland
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Your applicationOpen nowVerification & Compliance Specialistjob-room.ch · Rotkreuz, ZG, Switzerland
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This job: posted 6 days ago

The posting

Verification \& Compliance Specialist -------------------------------------

Roche Schweiz schlägt die Brücke zwischen Pharmazie und Diagnostik. Wichtige Forschungs- und Entwicklungsfunktionen sind hier angesiedelt. Für unsere langjährige Kundin, die Roche Diagnostics International AG in Rotkreuz, suchen wir eine/n

Verification \& Compliance Specialist =========================================

Hintergrund:

Zur Verstärkung des Regulatory Team suchen wir für einen Zeitraum von 6 Monaten eine erfahrene Person. In dieser Rolle übernehmen Sie die eigenverantwortliche regulatorische Verifizierung und Bewertung von Drittanbieter-Produkten (3rd Party Products) in Bezug auf die geltenden europäischen (EU-MDR / EU- IVDR) und schweizerischen Regularien (MepV / IvDV). Aufgaben \& Verantwortlichkeiten:

  • Regulatorische Verifizierung: Eigenständige Prüfung und Bewertung von Technischen Dokumentationen, Konformitätserklärungen (DoC), CE-Zertifikaten und Kennzeichnungen von 3rd- Party-Medizinprodukten und In-vitro-Diagnostika, Überprüfung der korrekten Kennzeichnung bzgl. CH-REP (Schweizer Bevollmächtigter) und Importeurspflichten gemäs MepV/IvDV
  • Vendor \& Partner Management: Kommunikation mit Lieferanten und Partnern zur Einforderung, Durchsicht und Klärung fehlender regulatorischer Nachweise und Qualitätsvereinbarungen
  • PRRC Unterstützung: Erstellung von Empfehlungen für die Freigabe oder Sperrung von Drittanbieter-Produkten für den Schweizer Markt
  • Operative unterstützung im Bereich Regulatory nach Bedarf: z.B. Lieferantenanfragen, Dokumentensichtung (nicht abschliessende Auflistung)

Anforderungen:

* Erfolgreich abgeschlossenes Studium im Bereich Medizintechnik, Naturwissenschaften, Wirtschaftsingenieurwesen oder eine vergleichbare Qualifikation * Regulatorische Expertise: Nachweisbare, mehrjährige (3+ Jahre) Berufserfahrung in Regulatory Affairs / Quality Management im Medtech- oder IVD-Sektor * Fundierte Kenntnisse * * Fokus: Schweizer In-vitro Diagnostik Verordnung (IvDV) * Schweizer Medizinprodukteverordnung (MepV) * Erfahrung mit 3rd-Party-Prozessen: Praktische Erfahrung in der Auditierung, Freigabe oder Verifizierung von Zulieferer- und Drittanbieter-Dokumentationen * Verhandlungssicheres Deutsch und Englisch in Wort und Schrift

Was Ihnen geboten wird:

  • Eine Chance, in einem der bedeutendsten Pharmaunternehmen der Welt mitzuwirken
  • Moderner Campus mit viel Grünflächen und Begegnungszonen
  • Zentrale Lage mit Autobahnanschluss und Bahnhof in der Nähe
  • Abwechslungsreiches Tätigkeitsprofil
  • Homeoffice Möglichkeit
  • Weiterbildungsmöglichkeiten durch temptraining
  • Mitarbeit in einem dynamischen und motivierten Team

Gerne können Sie Ihre vollständigen Bewerbungsunterlagen an Frau Diana Afonso senden.

Chemie Pharma Pharmacy Diagnostik Zug Luzern Verifikation Dokumentation Regulatory Affairs

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