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    Reference number: 873133/1

    Leitung Regulatory Affairs (m/w/d)

    Festanstellung durch unseren Kunden
    Köln
    • Leitung und Koordination des Regulatory-Affairs-Teams
    • Sicherstellung der Produkt- und Verkehrsfähigkeit gemäß geltender gesetzlicher Vorgaben
    • Bewertung regulatorischer Anforderungen, insbesondere im Kosmetik- und Chemikalienrecht (z.B. EU-KosmetikVO, REACH)
    • Prüfung und Freigabe von Produkttexten, Kennzeichnungen und Reinzeichnungen
    • Monitoring gesetzlicher Änderungen und Ableitung unternehmensweiter Maßnahmen
    • Ansprechpartner:in für Behörden, Kunden, Lieferanten und externe Experten
    • Enge Zusammenarbeit mit Einkauf, Vertrieb, Marketing und Produktentwicklung
    Online since: Thu May 07 08:09:20 CEST 2026
    Reference number: 860504/1

    Stellvertretende Responsible Person (m/w/d)

    Festanstellung durch unseren Kunden
    Potsdam
    • Unterstützung bei der Sicherstellung & Weiterentwicklung des GDP-konformen Qualitätssystems
    • Mitwirkung bei der Umsetzung regulatorischer Anforderungen (u.?a. §?52a AMG / §?2 AM-HandelsV)
    • Beteiligung an Rückrufen, Reklamationsbearbeitung und Selbstinspektionen
    • Unterstützung bei Entscheidungen zum Verbleib von Arzneimittelrückgaben
    • Mitarbeit bei Qualifizierung von Lieferanten & Freigabe ausgelagerter Tätigkeiten
    • Planung und Durchführung interner Schulungen sowie Pflege der qualitätsrelevanten Dokumentation
    • Mitwirkung bei Erstellung und Umsetzung von Quality Technical Agreements
    • Enge Zusammenarbeit mit RP, QA und weiteren internen Schnittstellen; Vertretung der RP nach entsprechender Einarbeitung
    Online since: Mon Mar 16 16:11:10 CET 2026
    Reference number: 863220/1

    Quality & Regulatory Affairs Manager – Digital Health / SaMD (m/w/d)

    Festanstellung durch unseren Kunden
    Magdeburg
    • Weiterentwicklung eines schlanken, risikobasierten Qualitätsmanagementsystems (ISO 13485, AI Act)
    • Sicherstellung regulatorischer Anforderungen für aktive Medizinprodukte, sterile Produkte sowie Software as a Medical Device (SaMD)
    • Vorbereitung, Koordination und Begleitung internationaler Zulassungs- und Registrierungsprozesse (EU/MDR, USA/FDA) inkl. Kommunikation mit Benannten Stellen, Behörden und externen Partnern
    • Erstellung moderner, nachvollziehbarer technischer Dokumentationen und Risikobewertungen
    • Steuerung regulatorischer Aufgabenpakete in enger Zusammenarbeit mit Entwicklung, Produktion und Service
    • Planung, Durchführung und Nachbereitung interner und externer Audits
    • Aktive Mitarbeit in einem interdisziplinären Umfeld, das Robotik, KI, Medizin und Engineering verbindet
    Online since: Tue Feb 24 16:14:34 CET 2026

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