Regulatory Affairs Officer

About the position

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.

 
Your Profile

  • Bachelor 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. 

 
Your application

Up for the challenge? 
We welcome your cv + motivation letter at melissa.moens@fujirebio.com by 12/08/2022.

 

Our Offer

By joining Fujirebio you contribute to a better healthcare in a company where different cultures meet each other which makes our jobs challenging and stimulating.

Our employees appreciate their rich job content and the great deal of independence within their job.

In an open, informal and dynamic work environment you will be collaborating with our scientific, commercial, operational and supportive teams. To support this collaboration and to support personal growth of all team members we offer our employees the opportunity to develop their knowledge, skills and talents.

 
About us

Our committed and engaged employees make that Fujirebio Europe (previously Innogenetics) provides innovative IVD solutions for healthcare all over the world. 

Our products and services allow doctors to make fast and accurate diagnosis in different disease fields like infectious diseases and neurological disorders. Based upon our high-quality testing, appropriate treatment can be started quickly. We strive at being the best in each disease field in offering the best and unique diagnostic solution.

We develop and manufacture diagnostic tests at our site in Ghent, as well as in Tokyo, after which they are sold worldwide by our commercial teams to hospitals and clinical labs. 
Furthermore, we use our advanced experience in development and manufacturing of Diagnostic solutions and our high-quality standards for contract manufacturing projects with third parties. 

Fujirebio Europe belongs to an international group (H.U.Group) with branches and colleagues in Asia, Europe and the USA.  We currently employ 145 people at the headquarters in Ghent and 50 people in our European affiliates. 

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