Regulatory & Ethics Committee Submission Coordinator - Penzberg, Deutschland - Franz & Wach Personalservice GmbH

Beschreibung

Your tasks at Roche Diagnostics:

• Prepares application forms for submissions to regulatory authority and if applicable, ethics committees for analytical performance studies under IVDR
• Reviews and adapts documents and templates relevant for submission
• Compiles submission packages
• Submits the applications for approval of a performance study under IVDR via the DMIDS and later the EUDAMED system
• is the first point of contact for queries from the Ethics Committee and the authority
• prepares and submits the answers to queries
• Oversight of CRO/CRA activities

The requirements:

• 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)

Franz & Wach is a signatory of the Diversity Charter. This job advertisement is basically addressed to people of any gender or age, any origin, orientation or identity

Your contact to us

1. Send us your resume via email to -

2. For further questions you can reach us at the telephone number: 08856 /

Through Franz & Wach we offer you an opportunity to join Roche Diagnostics GmbH in Penzberg.

We OFFER:

• Best salary, because we get the maximum out of it for you
• Contact at eye level - you are important to us Your satisfaction is important to us
• We respond to your wishes and plan your future together. The focus is always on your takeover
• We are specialized in the pharmaceutical industry and complete biotechnological training courses for this purpose.
• We know the decision makers* through our years of experience in the pharmaceutical industry
• We gained hundreds of recommendations from our former employees* who are now directly employed by Roche.
• From helper*, Career changer* to doctor* - We are the right place for you