Karrierechancen: Clinical Regulatory Associate
vor 2 Wochen
Clinical Regulatory Associate (m/w/d)
BIOTRONIK ist einer der weltweit führenden Hersteller kardio
- und endovaskulärer Implantate und Katheter für Herzrhythmusmanagement, Elektrophysiologie und Vaskuläre Intervention. Als weltweit tätiges Unternehmen mit Hauptsitz in Berlin entwickeln, produzieren und vertreiben wir qualitativ höchstwertige Medizinprodukte auf dem neuesten Stand von Forschung und Technologie. Unser Erfolg basiert auf der Kompetenz und der ergebnisorientierten Zusammenarbeit unserer Mitarbeiter:innen.
Nationale und internationale (prä-)klinische Studien zu hochkomplexen Medizinprodukten sind der Schwerpunkt unserer Abteilung Center for Clinical Research.
**Ihre Aufgaben**
- Einreichung von Antragsunterlagen international durchgeführter klinischer Studien bei Behörden (initial, Änderungsanzeigen, Beendigungsmeldungen)
- Zusammenstellung von Einreichungsunterlagen in Zusammenarbeit mit den Studienteams
- Kooperation mit lokalen Studienorganisationen zur Unterstützung nationaler Einreichungsaktivitäten
- Mitarbeit bei der Klärung von Anzeigepflichten gegenüber nationalen und internationalen Behörden
- Übernahme definierter Aufgaben innerhalb der Recherchen gesetzlicher Vorgaben
- Bereitstellung von Informationen für die Kommunikation in die zuständigen Fachabteilungen
- Aktualisierung und Pflege des Trial Master Files und des Clinical Trial Management Systems, u.a. mit länderspezifischen Informationen
**Ihr Profil**
- Abgeschlossene medizinische, technische oder kaufmännische Berufsausbildung
- Einschlägige Berufserfahrung in der klinischen Forschung (z.B. als Clinical Research Associate)
- Verständnis relevanter Regularien klinischer Studien, insbesondere für Medizinprodukte (MPDG, MDR, GCP, ISO 14155)
- Strukturierte, analytische Arbeitsweise
- Technische Affinität und Vertrautheit im Umgang mit Datenbanksystemen
- Fließende Deutsch
- und sehr gute Englischkenntnisse
**Was wir bieten**
- Attraktives Entgelt gemäß Tarif der Metall
- und Elektroindustrie (West)
- Familienfreundliche Arbeitszeiten durch flexibles Arbeitszeitmodell mit Kern
- und Gleitzeit
- Zahlreiche Benefits (Zuschüsse zu Kantine, betrieblicher Altersvorsorge, Jobticket)
- Persönliche und fachliche Weiterentwicklungsmöglichkeiten auf dem internen Arbeitsmarkt
- Umfassende Gesundheitsvorsorge (Vergünstigungen in Fitnessketten, Gesundheitstage, Betriebssportgruppen)
Haben wir Ihr Interesse geweckt? Dann bewerben Sie sich bitte online über unser Bewerbermanagementsystem Wir freuen uns auf Sie.
Standort: Berlin| Arbeitszeit: Vollzeit | Vertragsart: Unbefristet
Kennziffer: 58339 | Ansprechpartnerin: Maria Roreger | Tel. +49 (0) 30 68905 3575
Schwerbehinderte Menschen werden bei gleicher Eignung bevorzugt berücksichtigt. Es besteht grundsätzlich auch die Möglichkeit der Teilzeitbeschäftigung.
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