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Guerbet est un leader mondial de l'imagerie médicale, proposant une large gamme de produits pharmaceutiques, de dispositifs médicaux, de solutions numériques et d'IA pour l'imagerie diagnostique et interventionnelle, afin d'améliorer le diagnostic et le traitement des patients.

Pionnier depuis plus de 90 ans dans le domaine des produits de contraste, Guerbet innove en permanence avec 9% des revenus dédiés à la Recherche & Développement et quatre centres en France, en Israël et aux États-Unis.

Guerbet (GBT) est cotée sur Euronext Paris (segment B - mid caps) et a réalisé un chiffre d'affaires de 817 millions d'euros en 2019 avec plus de 2 800 collaborateurs dans le monde.

Achieve, Coorperate , Care et Innovate  sont les valeurs que les employés de Guerbet partagent et pratiquent chaque jour. Travailler chez Guerbet, c'est jouer un rôle unique dans l'avenir de l'imagerie médicale. Passionnée par son métier, l'entreprise s'efforce jour après jour de conjuguer performance, qualité et développement durable.

Pour plus d'informations sur Guerbet, rendez-vous sur www.guerbet.com  et suivez Guerbet sur Twitter @GuerbetGroup

EU MDR Project Leader

Description

What is the project about ? 

There is a new regulation, called Medical Device Regulation, MDR, which replaces the existing directive, MDD.

This new Regulation (EU) 2017/745 on medical devices becomes applicable on 25 May 2020.

The objective of the project is the conformity of products (Medical Devices and kits) and organizations of Guerbet group with this new regulation.

  • Manufacturers must be re-certified: After May 2020, no manufacturer may be certified to put Medical devices on the European market if it is not certified under the new regulation.
  • Products must be re-certified: After May 27, 2024 no more devices may be placed on the European market under an old certificate (more detail on the deadlines are explained below).

 

What will be your role ? 

As a Project Manager you will be in charge of the implementation of the MDR Regulation within Guerbet. The project team will be composed of our quality, regulatory affairs, phamacovigilence and strategic project departments.

Your missions will include: 

  • Analyzing carefully the new MDR and define its impact on Guerbet Group
  • Reviewing all products labelling as well as product technical documentations, organization and procedures
  • Reviewing the organization of distribution within the group: make sure all distributors respond to the new regulation

What is the team expected to deliver ?

  • Procedures and organization:
    • New procedures and updated intercompany agreements for:
      • Guerbet SA as EC Representative
      • Guerbet SA as Importer
      • All affiliates and other external agents as Distributors
    • Definition of a responsible person for:
      • each legal manufacturer
      • each EC Representative
  • Certifications:
    • Manufacturers’ “CE re-certification” by Notified Bodies (Quality Systems, Risks Assessment, Post Market Surveillance, Clinical Evaluation, Vigilance …)
    • Products’ re-certification: new Declarations of Conformity and new CE certificates
  • Product documentation:
    • Revised Technical Documentation for each commercialized product (23 Safety & Performances Requirements (SPR) replace the 13 Essential Requirements)
    • Revised CER (Clinical Evaluation Reports) for each commercialized product
  • Products:
    • Labeling update of all products, to add new mandatory texts or updates (e.g. addition of the Importer Name & Address on all the LF products), including UDI requirements when applicable.
  • Portfolio analysis: The new regulation may imply that current commercialization of some products are no more profitable:
    • Analysis on currently manufactured products
    • Analysis on currently distributed products.

Compétences requises

You are an engineer/project manager with an experience of 3 to 5 years working on Medical Devices (Quality, R&D, Marketing etc.)

The global impact of this new regulations requires to speak english fluently in order to communicate with all subsidiaries. 

You are able to manage a team functionnaly