Teamleader Medical Device Reporting

vor 9 Stunden


Kanton Solothurn, Schweiz Ypsomed Vollzeit

Im Bereich Quality Management in der Abteilung Complaint Management & Vigilance suchen wir am Standort Solothurn eine technische versierte Persönlichkeit als

**Teamleader Medical Device Reporting & PMS**:
**Ref-Nr. 3554**:
**100%**:
**Teamleader Medical Device Reporting & PMS**:
**100%**:
**Ihre Hauptaufgaben**:

- Technische und organisatorische Führung Vigilance & Post Market Surveillance
- Verwaltung von Benutzerzugänge und -verwaltung von EUDAMED Datenbank Rechten
- Koordination bei der Einspielung sämtlicher relevanten Daten. Sammeln und Pflege der Produktdaten
- Identifikation von regulatorischen Anforderungen und abbilden von Prozessabläufen
- Durchführung von Vigilance Meldungen. Pflege der Vigilanz
- und Trend-Reports in der EUDAMED Datenbank
- Direkter Ansprechpartner für interne Schnittstellen
- Teilnahme an produktspezifischen Product Care oder Projekt Meetings
- Projektarbeit gemäss Vorgaben des Vorgesetzten
- Mitarbeit bei QM-Aufgaben wie z.B. Erstellen von Vorgabedokumenten, Schulungen, Teilnahme und Audits
- Überwachung und Pflege der Rollen (Inverkehrbringer, Distributor, Importeur) und periodische Bestätigung

**Ihr Profil**:

- Abgeschlossene kaufmännische oder technische Berufslehre
- Erfahrung im Bereich Vigilance und PMS Prozess für medizintechnischen Bereich
- Regulatorische und Qualitätsmanagement bezogene Weiterbildung
- Sehr gute mündliche und schriftliche Sprachkenntnisse in Deutsch und Englisch (B2)

**Ihre Perspektive**:
Sie finden bei uns interessante Arbeitsinhalte, gute Entwicklungschancen sowie attraktive Anstellungsbedingungen. Wir bieten Ihnen die Gelegenheit, die innovations
- und qualitätsorientierte Welt der Medizintechnik ein Stück weit mitzugestalten.
Wir freuen uns auf Ihre Online-Bewerbung mit Angabe Ihrer Verfügbarkeit (Kündigungsfrist) und Ihrer Lohnvorstellung.



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