Informationen zur Anzeige:
Koordinator für Zulassungs- und Ethikkommissionsanträge
Hays Professional Solutions GmbH Standort Penzberg
Penzberg (DE)
Aktualität: 15.05.2024
Anzeigeninhalt:
15.05.2024, Hays Professional Solutions GmbH Standort Penzberg
Penzberg (DE)
Koordinator für Zulassungs- und Ethikkommissionsanträge
Ihre Aufgaben:
- Prepare application forms for submissions to regulatory authority and if applicable, ethics committees for analytical performance studies under IVDR
- Review and adapts documents and templates relevant for submission
- Compile submission packages
- Submit the applications for approval of a performance study under IVDR via the DMIDS and later the EUDAMED system
- First point of contact for queries from the Ethics Committee and the authority
- Prepare and submits the answers to queries
- Oversight of CRO/CRA activities
Das bringen Sie mit:
- Bachelor /Masters Degree in Life Sciences (PHD would be ok)
- Solid professional experience as CRA/Study Manager/ Clinical Associate/ Regulatory in the Diagnostics Industry (Applications without professional experience cannot be considered)
- Knowledge in IVDR, MPDG
- Fluent in English and German (Communication with German Authorities)
Standorte