Vigilance Officer (medical devices)

Région
vlaams brabant
Publication
mercredi 4 octobre 2017
Date limite
samedi 4 novembre 2017
Réf
739DEXPE-BE
Contact
Sandra Rizzuto
Fonction
Autre
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Vigilance Officer (medical devices) Organisation description:

As part of this complaint & vigilance department, the main responsibilities of the MD (medical devices) Vigilance Officer is to support the MD Vigilance Specialist in co-ordinating, executing and reporting the post market surveillance of the devices related to customer complaints and resulting vigilance and field safety actions, and to promote their correction and prevention. A Medical devices company, you will be working for the complaint and vigilance department.

Job description:

Co-ordinate the handling of Customer Product Complaints Input, follow-up to closure of the customer product complaints between Sales and the manufacturers for the territory and for all the products Support in handling and follow up of samples related to complaints. Support the Vigilance reporting Assist in the preparation, issue and follow-up of vigilance reports by manufacturers Support the coordination of Field Safety Corrective Actions [FSCA] Assist in the preparation, issue and follow-up of FSCA decided by manufacturers As periodically instructed, assist in conducting a Mock FSCA to test and improve the process General support Maintain updated procedures related to the function Train associates to customer complaint handling Assist in the regular reporting on achievement, trending and quality issues to company management Promote total quality, company policies and regulatory compliance/ requirements

Profile:

Bachelor or master in medical / pharmaceutical / scientific / biomedical oriented education Good knowledge of statistical methodology is an asset. Having an accurate way of working. Former experience in Regulatory Affairs, Quality Assurance, complaint handling or Medical Device Engineering is an asset Excellent working knowledge of English (written and spoken). Dutch is an asset.

Offer:

Fix contract with interesting advantages



Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713