Regulatory affairs Manager

WHAT ARE YOUR RESPONSIBILITIES?

  • You will obtain registration approvals from national authorities, on a global scale
  • You will keep current valid registrations alive by respecting deadlines and expiry dates
  • You will keep the technical documentation from the registration files up-to-date to the latest ISO-norms and regulations
  • You will comply to regulatory compliance (material / labelling) before batch release
  • You will follow-up on Post-market surveillance obligations
  • You will gather all regulatory relevant information from our registrations and create an up-to-date registration database that is accessible (not editable) by the entire team

WHO ARE WE LOOKING FOR?

  • You have a master’s degree in life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer, engineering…) 
  • You have previous RA experience and you can interpret laws, guideness and directives
  • You have expertise in Preparing international regulatory submission files of IVD’s and MD’s according to the current regional registration guidelines to obtain swift approvals. 
  • You have expertise in Regulatory strategy & networking: maintaining good contacts with local authorities, consultants, agents and the distributors. 
  • You have good organization skills and a critical mindset
  • You have experience with MS Project and MS Office 
  • You have good writing skills in Dutch or French and English
  • You have the Willingness to travel in case of regulatory necessity or to improve regulatory networking 

WHAT DOES QBD OFFER YOU?

  • A young, dynamic company with a let’s go for it mind-set, a no-nonsense approach, and a culture of openness and transparency
  • Personal and professional development through guidance, education and knowledge sharing
  • A competence development model focused on your personal ambitions
  • An attractive salary package, including a variety of extralegal benefits such as a company car, fuel card, mobile phone, etc.

Interested? Apply now by sending us your CV and motivation.