Regulatory Affairs Manager
Vor 2 Tagen
Unser Mandat ist ein innovatives und global vernetztes Medizintechnikunternehmen, welches für sein Entwicklungs-Know-How im Bereich der medizinischen Diagnostik bekannt ist. Mit mehr als 15 Jahren Erfahrung und 100 Mitarbeitern in 4 Niederlassungen verzeichnet unser Mandant in den letzten Jahren ein starkes Wachstum und sucht zum nächstmöglichen Zeitpunkt Unterstützung durch einen **Regulatory Affairs Manager (m/w/d)** für die Niederlassung im Grossraum Luzern.
**Aufgabengebiet**
- Zuständig für die Vorbereitung und Unterstützung von internen Audits und Audits zur CE Zertifizierung des Medizinproduktes und des QM Systems nach ISO 13485
- Sie wirken bei der Koordination von Tätigkeiten im Bereich der Regulatory Affairs mit (insb. bei der Zulassung und Aufrechterhaltung)
- Mitarbeit in Projektteams und Schnittstelle zu anderen Fachabteilungen hinsichtlich der regulatorischen Anforderungen bei der Entwicklung und Erstellung sowie Aktualisierung von Dokumentationen
- Sie verantworten die Korrespondenz, Kommunikation und Kontaktpflege mit internationalen Partnern sowie Distributoren
**Anforderungsprofil**
- Vorzugsweise Studium der Naturwissenschaften, Medizintechnik oder abgeschlossene berufliche Ausbildung in vergleichbarer Fachrichtung
- Sie verfügen über Kenntnisse nationaler und internationaler Zulassungsverfahren
- Sie bringen Berufserfahrung im Bereich Regulatory Affairs oder Qualitätsmanagement mit
- Sie sind mit den Normen ISO 13485 und ISO 9001 vertraut
- Teamfähigkeit sowie sehr gute Deutsch
- und Englischkenntnisse in Wort und Schrift runden Ihr Profil ab
**Vergütungspaket**
- Attraktives Vergütungsmodell
- Betriebliche Altersvorsorge und vermögenswirksamen Leistungen
- Angenehme und persönliche Arbeitsatmosphäre in einem hochmotivierten Team
- Modern ausgestattete Arbeitsplätze
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