Regulatory Affairs Clinical Writing Professional (w/m/d)
Fresenius SE & Co. KGaA
- Vollzeit – Unbefristet – Mobiles Arbeiten teilweise möglich – Als Regulatory Affairs Clinical Writing Professional übernehmen Sie eine Schlüsselrolle in der klinischen Bewertung und klinisch‑regulatorischen Dokumentation unserer Medizinprodukte. Sie gestalten den gesamten Produktlebenszyklus aktiv mit – von der Planung klinischer Bewertungen über die Erstellung zentraler Dokumente bis hin zur Post‑Market‑Surveillance. Ihre Arbeit trägt direkt dazu bei, Sicherheit, Leistungsfähigkeit und regulatorische Konformität unserer Produkte weltweit sicherzustellen. Aufgaben und Verantwortlichkeiten Klinische Bewertungen erstellen und aktualisieren über den gesamten Produktlebenszyklus Regulatorische Anforderungen sicherstellen (EU MDR, FDA) Studienprotokolle entwickeln inkl. Ein-/Ausschlusskriterien, Endpunkten und Methoden, sofern erforderlich Interdisziplinär zusammenarbeiten mit R&D, RA, QA und Marketing Literaturrecherchen und Datenanalysen durchführen zur klinischen Evidenz Risikobewertungen durchführen und in die klinische Bewertung integrieren Post‑Market‑Surveillance unterstützen (PMS‑Pläne, PSURs, PMCF, Trendanalysen) Fachliche Qualifikationen und Kompetenzen Abgeschlossenes wissenschaftliches Studium (Medizin, Biomedizintechnik, Naturwissenschaften o.Ä.) Fundierte Kenntnisse klinischer Forschung und Regulierung im Medizinproduktebereich Erfahrung mit statistischen Auswertungen und klinischen Bewertungsmethoden Starke Projektmanagement‑ und Kommunikationsfähigkeiten Selbstständige, strukturierte und zuverlässige Arbeitsweise Teamfähigkeit in interdisziplinären und internationalen Umfeldern Hohe Detailgenauigkeit und Qualitätsbewusstsein #J-18808-Ljbffr Fresenius SE & Co. KGaA
Vacancy posted 3 days ago
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