Regulatory Affairs Manager

Regulatory Affairs Manager - Regulatory Support, R hence we well understand what it means to be professionally supported in your search for a new project and being employed.

Reference No.: 916128

Role: Regulatory Affairs Manager

Industry: Pharmaceutical

Location: Luzern und Region

Workload: 100%

Start Date: 03/01/2017

Duration: To 31/10/2017

Project:

- Project Lead Regulatory, within the scope of a project for new products or during the product life cycle
- Provides regulatory support to the R&D Project teams with the applicable Design Control processes
- Provides team members ad hoc specific education
- provides qualification and classification of the development object and related sumission strategy
- Interfaces with the correspondent RA-FL for submission strategies, planning and support
- Escalates 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
- Regulatory/Design Quality for several years for IVD or Medical Devices preferred for Software and instruments
- 5 years experience in Medical Device or IVD industry
- Good knowledge of Microsoft Office

Education:
University Degree

Languages:
English - Advanced

Should you find yourself suitable for this position then send your complete dossier using this link in the advert.

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