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, guidelines 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 monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.

But most of all..

  • Working for the Flemish Young Entrepreneur of 2019!
  • A flat organization in the broadest sense of the word
  • An increase in your IQ through our extensive training package
  • A hip office with air hockey table
  • More muscle mass through our weekly boot camps
  • 32 vacation days that you wish were fewer (because it's great to work here 😉 )
  • In short … We work, we play, we deliver, we are Quality by Design!

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