Mdr Project Leader H/F (64 vues)

Villepinte - 93
6 décembre 2018
Le job
Guerbet is a human-scale company that aims to become a new global leader in medical imaging.
Pioneer in contrast media with more than 90 years'​ experience, Guerbet is the only pharmaceutical group dedicated to medical imaging worldwide, with a presence in almost 80 countries via a network of subsidiaries and distributors.
Guerbet offers a comprehensive range of imaging products, solutions and services for Diagnostic Imaging (CT/Cath Lab examinations, Magnetic Resonance Imaging (MRI)) and Interventional Imaging (Contrast agents and medical devices).
More than 60, 000 health professionals rely on Guerbet's contrast agents. Advancing in innovation solutions, the diagnosis of major diseases (cardiovascular diseases, cancers, diseases of the central nervous system) and interventional radiology while reconciling efficacy and cost containment, are at the heart of Guerbet's mission.
Its total workforce is of 2, 700 employees. Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.
For more information about Guerbet, please GO to www.guerbet.com and follow Guerbet on Twitter @GuerbetGroup

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) 2017/745on 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 et 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 et 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.
Le profil idéal
Required skills

You are an engineer/project manager with an experience of 3 to 5 years working on Medical Devices (Quality, RetD, 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