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RA Officer - Belgium  

Company managed [?] Still accepting applications

Posted on : 10 July 2017

Project Description

Description:
To support our strategy we are strengthening our regulatory affairs team with an RA Officer position.


Accountabilities
  •  You support the sales of our company established diagnostic products by obtaining and maintaining world-wide licenses in line with applicable regulations. You collect necessary data and coordinate submission and follow-up of registration/renewal files.  
  •  You act as contact person for the authorities and other internal/external partners concerning the status and follow-up of a product registration  
  •  You assist in the preparation of incident reports based on the information provided by RA representative of the Risk Assessment Committee, and you will follow-up on incident reports within the required timelines and in accordance with the regulatory requirements.  
  •  You will be responsible for the maintenance of the regulatory intelligence databases  
  •  Your job will involve interaction with various internal/external partners (affiliates, distributors, competent authorities, notified body, RA consultants, ...)  


Profile
  • Bachelor degree in medical or life sciences or equivalent by experience 
  • Strong interest in regulatory frameworks 
  • 2 à 3 year of regulatory affairs experience is a plus 
  • Accurate and reliable administrative skills 
  • Good knowledge of MS office Word and Excel 
  • Positive and pro-active attitude 
  • Good problem solving – problem analysis 
  • Team-player 
  • Communication with impact: good advisory skills 
  • Languages: Dutch & English – good knowledge written & spoken.