Clinical Affairs and Vigilance Manager
vor 1 Woche
Für den Ausbau unseres klinischen Teams suchen wir einen
Clinical Affairs and Vigilance Manager - 100% (m/w/d)
Ihre Hauptaufgaben
- Planung und Durchführung von Aktivitäten zur Marktüberwachung (Vigilanz):
- Erfassen und Analysieren von Vorkommnissen
- Meldungen von Vorkommnissen, FSCA, FSN an Nationale Behörden
- Durchführung von klinischen Bewertungen
- Planung und Durchführung von Aktivitäten zur klinischen Überwachung nach dem Inverkehrbringen (PMCF)
- Unterstützung bei der Planung und Durchführung klinischer Prüfungen von Medizinprodukten nach EN ISO 14155 und MDR 2017/745
Ihr Profil
- Hochschulabschluss im Bereich Gesundheitswissenschaften, Lebenswissenschaften, Medizintechnik oder vergleichbar
- Relevante Berufserfahrung
- Fortgeschrittene Kenntnisse im wissenschaftlichen Arbeiten, insbesondere im Bereich der evidenzbasierten Medizin
- Erfahrung in der systematischen Bewertung klinischer Daten und Erstellung wissenschaftlicher Berichte
- Erfahrungen in der klinischen Forschung sind wünschenswert
- Kenntnisse relevanter gesetzlicher, regulatorischer und normativer Vorgaben (MDR 2017/745, MEDDEV 2.7/1 Rev.4, MEDDEV 2.12-1 Rev.8, EN ISO 14155, MDCG)
- Präzise und selbstständige Arbeitsweise
- Kommunikationsstärke, Teamfähigkeit und Eigeninitiative
- Sehr gute Deutsch
- und Englischkenntnisse in Wort und Schrift
Wir bieten
- Einen interessanten und modernen Arbeitsplatz in einem innovativen und wachsenden Unternehmen
- Eine spannende Tätigkeit in einer zukunftsträchtigen Branche
- Eine umfassende und gezielte Einführung und eine kollegiale Arbeitsatmosphäre
- Ein hohes Mass an eigenverantwortlicher Arbeitsorganisation
- Flexible Arbeitszeiten und gute Sozialleistungen
Wir suchen eine selbstständige und verantwortungsbewusste Persönlichkeit. Sie zeichnen sich durch eine analytische Denkweise, Teamfähigkeit, Zielorientierung und exakte Arbeitsweise aus. Zudem arbeiten Sie zuverlässig mit sehr hohem Qualitätsbewusstsein.
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