Mediziner Regulatory Support Expert Immundiagnostik
vor 3 Wochen
**Mediziner Regulatory Support Expert Immundiagnostik (m/w/d)**
Für einen Spezialisten im Bereich Immundiagnostik in Hamburg suchen wir ab sofort einen Mediziner (m/w/d) als Regulatory Support Expert im Bereich Regulatory Affairs in Personalvermittlung.
Ihre Aufgaben:
- Erstellung von technischen Files zur Aufrechterhaltung des regulatorischen Status nach Aktualisierung des technischen Files (IVDR)
- Ansprechpartner für die Einreichung und Rückfragen in Bezug zu technischen Files und von klinischen Datensätzen
- Erstellung von Regulatory Strategies und Bewertungen von Projekten Produktklassifizierungen und Produktregistrierungen (MDSAP- sowie andere Länder)
- Durchführung von regulatorischen und klinischen Aufgaben nach dem Qualitätsmanagement-Handbuch
- Umsetzung von Gesetzestexten beziehungsweise Produktnormen
- Schnittstelle und aktive Kommunikation zu allen Abteilungen
- Freigabe von IFUs, Marketingmaterial und Label
Ihr Profil:
- Erfolgreich abgeschlossenes Studium im Bereich Medizin, Biotechnologie, Pharmazie oder Chemie
- Mehrjährige einschlägige Berufserfahrung in der In-vitro-Diagnostik oder im Bereich Medizinprodukte in einer vergleichbaren Position, mit regulatorischer Aufgabenstellung
- Verhandlungssichere Deutsch
- und Englischkenntnisse in Wort und Schrift
- Sichere Kenntnisse in MS Office, Outlook und Adobe
- Fachkenntnisse in GMP, Regulation 2017/746, Directive 98/79/EC / ISO 13485:2016
Ihre Vorteile bei unserem Kunden
- 13. Gehalt, vermögenswirksame Leistungen und eine betriebliche Altersvorsorge
- Mitarbeiterveranstaltungen
- Frisches Obst und Gemüse
- Flexible Arbeitszeiten und 30 Tage Urlaub im Jahr
Ansprechpartner
Angela Kersten
040 780 19 32 12
Ich freue mich, von Ihnen zu hören.
Karriere bei JOB Kontor - und die Chemie stimmt
Die JOB Kontor GmbH ist in Hamburg der führende Personaldienstleister auf dem Gebiet der naturwissenschaftlichen Berufe. Unsere Mitarbeiter und Mitarbeiterinnen sind qualifizierte Fach
- und Führungskräfte aus diesem Bereich. Wir ermöglichen den Einstieg in namhafte Unternehmen der Chemie-, Pharma
- und Biologiebranche.
Wir freuen uns auf Ihre vollständigen Bewerbungsunterlagen, bevorzugt per Bewerbungsformular auf unserer Homepage oder E-Mail. Für Informationen vorab stehen wir Ihnen gerne unter der angegebenen Telefonnummer zur Verfügung.
Beachten Sie bitte unsere Datenschutzerklärung.
Art der Stelle: Vollzeit, Festanstellung
Arbeitszeiten:
- Keine Wochenenden
- Montag bis Freitag
Leistungen:
- Betriebliche Altersvorsorge
- Betriebsfeiern
- Flexible Arbeitszeiten
- Kostenloses oder Vergünstigtes Essen
- Zusätzliche Urlaubstage
Sonderzahlungen:
- 13. Monatsgehalt
Arbeitsort: Ein Arbeitsort
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