Koordinator für Zulassungs- und Ethikkommissionsanträge (m/f/d)
Your responsibilities
- 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
Your profile
- 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)
Your benefits
- 30 days leave per year
- A highly motivated team and an open way of communication
- A very renowned company
About 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.
Staffing process for a permanent or temporary position
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We will review your application documents and carry out a detailed analysis of your professional qualification.
Your contact at Hays
+ 49 621 1788-4297© Copyright Hays plc, . The HAYS word, the H devices, 'Hays Working for your tomorrow' and 'Powering the world of work' and associated logos and artwork are trademarks of Hays PLC. The H devices are original designs protected by registration in many countries. All rights are reserved.