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.