CDI
> Bac + 5
Provence-Alpes-Côte d'Azur
entre 50K€ et 60K€
Recherche clinique / Affaires médicales

La société EUROS est une entreprise d'environ 70 personnes basée à La Ciotat depuis 25 ans qui conçoit, fabrique, et distribue des implants orthopédiques (prothèses de genou, de hanche, d'épaule, de rachis, et de pied) en France et à l'international.

Le poste

MISSION :

- Lead and Manage Clinical evaluation;

- Lead and Manage PMCF study. DESCRIPTION DES FONCTIONS Clinical evaluation part:

• Lead clinical evaluation on EUROS devices in compliance with MEDDEV 2.7.1 and EUROS procedures;

• Select the proper predicate and justify methodically biological, technical and clinical equivalency with EUROS device subject to study;

• Select methodically relevant literature and analyse scientific data;

• If no equivalency can be done, lead clinical investigation (protocol definition, administrative submissions, follow up) to demonstrate clinical safety and performance of the device;

• Define clinical evaluation frequency update in compliance with regulatory requirements; PMCF part:

• Define, with project team, the Post Market Clinical Follow (PMCF) plan per EUROS device;

• Define PMCF protocols in compliance with MEDDEV 2.12 and EUROS procedures and validate them;

• Manage administrative submissions in order to perform PMCF studies;

• Organize data collection in such a way to minimize expenses and to use EUROS clinical department resources ideally according to their activities and load;

• Manage PMCF reports update planning;

• Organize products publication according Management and activities optimisation part :

• Communicate with the different departments (R&D, Marketing, QARA, Finance…) in order to help them as much and fast as possible to achieve the overall goal;

• Anticipate new constraints and organize conformity (be flexible in terms of activities and ways of conducting them);

• Bring forward proposals to support clinically marketing strategy in term of products;

• Propose new tools which would enable to optimize clinical activities and improve EUROS image to doctors to create a change control team that lead the implementation of such tools ;

• Participate to identification, analysis, selection and implementation of such tools;

Profil recherché

COMPETENCES ET APTITUDES REQUISES DIPLOMES - Bac +5 minimum.

EXPERIENCE / COMPETENCES :

- Minimum 5 ans dans les dispositifs médicaux ;

- Expérience en Investigation Clinique et en Evaluation Clinique des Dispositifs Médicaux ;

- Maitrise de la veille concurrentielle ;

- Connaissances des bonnes pratiques des études cliniques ;

- Connaissance de la réglementation dans le domaine des dispositifs médicaux (Directive 93/42CEE et normes harmonisées) ;

- Connaissance dans la gestion documentaire ;

- Leadership pour fédérer les équipes ;

- Organisé(e), pertinent, pragmatique, dynamique et performant.

AUTRES : (ex : langues, logiciels…)

- Maitrise du Pack office ;

- Anglais courant (lu parlé écrit).

Où postuler ? Personne chargée de ce recrutement

NIRISSIAN Diana GRH

recrutement@euros.fr