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Regulatory Affairs Officer

Apply here

Aline Vandermeeren
Business Unit Manager


Apply here

Aline Vandermeeren
Business Unit Manager



Aline Vandermeeren
Business Unit Manager
+32 497 71 58 10


Job description

In taking up this job you contribute to acquire and retain regulatory approval and licenses for our diagnostic products and systems and thereby guarantee continued sales eligibility. You will interact with different internal and external partners like the Product Development team, international commercial team, distributors, competent authorities, notified bodies, …

Your key tasks will be to:

  • collect necessary data to set up registration/renewal files;
  • organize meetings with all related parties to discuss and align on the content of the registration/renewal file
  • coordinate file submissions and follow up on registration/renewal files;
  • act as contact person for the authorities and internal/external partners concerning the status and follow-up of product registration;
  • initiate and follow-up requests for official documents for registration and sales purposes;
  • obtain and maintain good knowledge of the applicable legislations/directives and internal quality procedures;
  • prepare and follow-up on incident reports according to the regulatory requirements;
  • participate as regulatory affairs expert in project teams for the design and development of new products;
  • maintain the regulatory intelligence database and regulatory status of products.

 

Profile

  • Degree in medical or biological field 
  • Strong interest in regulatory frameworks
  • Accurate and reliable administrative skills
  • Good knowledge of MS office Word and Excel
  • Positive and pro-active attitude
  • Good problem solving and analytical skills
  • Team-player
  • Communication with impact and good advisory skills
  • Languages: Dutch & English – good knowledge written & spoken. 

Apply now for Regulatory Affairs Officer

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Contact details

Education and experience

Number of years of experience*
+32 497 71 58 10