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Location: 

Kortrijk, BE

Date: 
Job ID:  108

Regulatory Officer

Barco designs technology that makes everyday life a little better. Seeing beyond the image, we develop sight, sound, and sharing solutions to help you work together, share insights, and wow audiences. Our focus is on three core markets: Enterprise (from meeting and control rooms to corporate spaces), Healthcare (from the radiology department to the operating room), and Entertainment (from movie theaters to live events and attractions). With a team of over 3,600 employees, located all around the globe, we realized sales of 1,082.6 million euro in 2019. 

Function

 

We are currently looking for a Regulatory Affairs Officer to join the Barco Quality & Regulatory team in the Healthcare division. This division designs and manufactures medical devices for diagnostic & surgical imaging in different highly regulated medical markets. 
The regulatory officer participates in development project teams to ensure the regulatory documentation requirements are fulfilled and conducts the medical device submission and country registrations.

 

 
Key responsibilities 

 

 

  • You define and document the regulatory strategy for new product development projects
  • You deliver the regulatory documentation during product development
  • You are responsible for the preparation, conduct, and follow-up of submissions to international regulatory bodies
  • You are accountable for worldwide product and UDI (unique device identifications) registrations
  • You release or block shipments in line with the applicable medical device registrations
  • You assess the regulatory impact and approve product design changes
  • You follow up worldwide regulatory requirements related to medical devices
  • You manage and respond to customers regulatory requests
  • You report to the QA & Regulatory manager and work from the headquarters in Kortrijk

 

 

Your profile
 

  • You hold a higher educational degree in a scientific field 
  • You are strongly interested to investigate medical device regulations (like MDD/MDR, FDA, Health Canada, etc.)   
  • You have good verbal and written communication skills in English, combined with attention to details 
  • You have good organizational and time management skills 
  • You are a strong team player who’s able to motivate others & take ownership in a group when required 
  • You are a self-starter