Beschreibung
Regulatory Affairs Manager
About us: ITech Consult AG is a certified ISO Swiss company with offices also located in Germany, Great Britain and Ireland. ITech Consult is specialised in delivering ICT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.
Reference No.: 916084NC
Role: Regulatory Affairs Manager
Industry: Pharmaceutical
Location: Luzern und region; Switzerland
Workload: 100%
Start Date: ASAP
Duration: Till 31.10.2017
Responsibilities:
Project Lead Regulatory, within the scope of a project for new products or during the product life cycle:
-Provide regulatory support to the R&D Project teams with the applicable Design Control processes
-Provide team members ad hoc specific education
-Provide qualification and classification of the development object and related submission strategy
-Interface with the correspondent RA-FL for submission strategies, planning and support
-Escalate project related regulatory issues
-Review of labelling
-Assemble the documents and the project deliverable (or coordinate the activities) for the preparation of world-wide registration and resolution of possible conflicts
-Administration of Product declarations, Certificates and other, similar documents
Requirements:
-Support of IVD instrument development and life cycle management of product registrations
-5 years' experience in Medical Device or IVD industry
-Regulatory/Design Quality for several years within IVD or Medical Devices, preferred for software and instruments
-Fluent English (written and spoken)
-University degree in a pharma related field
Should you find yourself suitable for this position then send your complete dossier using this link in the advert.
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