Medical Device Vigilance Specialist (H/F)

Recruteur
UNIQUE
Région
LOUVAIN-LA-NEUVE
Publication
mercredi 1 août 2018
Date limite
samedi 1 septembre 2018
Réf
111172UNQ-BE
Contact
Unique Wavre Office
Niveau d'expérience
2 à 5 ans d'expérience
Type de contrat
CDD
Temps de travail
Temps plein
As a trusted HR partner, Unique helps you achieve your ambitions. With 40 years of experience, we are among the best Belgian service providers. More than 200 employees in more than 40 branches guarantee a personalized approach, adapted to qualified candidates and demanding companies. And this, through our six specializations Unique Office, Unique Technicum, Unique Finance, Unique Customer Care, Unique Human Resources and Unique Maritime.



Job Description

General mission:

The Medical Device Vigilance Specialist is responsible for maintaining the Medical Device Vigilance processes and ensuring related operational activities within the whole organization.

Main tasks:

Identify necessary inputs for Medical Device Vigilance.

Analyze data received related to quality, safety or performances of medical devices after they have been placed on the market and record analysis output.

Ensure follow up of safety complaints (issues raising a risk of harm to someone excluding employees of the company ).

Prepare customer or internal communication for safety complaints deemed necessary with support of other departments.

Analyze safety complaints and output of trends in complaints and incidents to determine and document the need to report to competent authorities based on regulations and risk assessment.

Prepare and submit the report to competent authorities in a timely manner.

Follow up implementation of corrective and preventive actions until report final closure.

Handle interaction with the US agent for FDA, notified body, other competent authorities and stakeholders which need to be involved in Medical Device Vigilance of products (e.g. technical and risk experts, marketing authorization holders).



Job Requirements

Profile

- Knowledge of Medical Devices Directive mandatory

- Background: Medical, clinical or scientific (may be also a nurse, a doctor, …)

- Junior profiles are also welcome

- Very good English knowledge

- Well organized

- Analytical

- Proactive



Salary and Benefits

Our client, a company active worldwide in the field of biotechnology, offers you a 6 - month mission from the end of August to the end of October with the possibility of a fixed contract.

Your salary package will be based on your experience and your skills.