Koordinator für Zulassungs- und Ethikkommissionsanträge

Detailansicht des Stellenangebots Stellendetails zu: Koordinator für Zulassungs- und Ethikkommissionsanträge Koordinator für Zulassungs- und EthikkommissionsanträgeKopfbereichArbeitInformatiker/in (Hochschule)Koordinator für Zulassungs- und EthikkommissionsanträgeHays Professional Solutions GmbH Standort PenzbergVollzeitPenzbergab sofortbefristet für 18 MonateGesternStellenbeschreibungVergütung: ab E8 - WestStelle im Rahmen der ArbeitnehmerüberlassungIhre 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

Ihre Qualifikationen

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)

Ihre Vorteile

30 days leave per year
A highly motivated team and an open way of communication
A very renowned company
Über Hays:
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages - completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Arbeitsorte82377 Penzberg