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Regulatory Affairs Manager

Eingestellt von ITech Consult

Gesuchte Skills: Support, Design

Projektbeschreibung

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.: 916128NC

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

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Projektdetails

  • Einsatzort:

    Luzern, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    Till 31.10.2017

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

ITech Consult