For one of our clients we are currently looking for a:
Medical Device Regulatory Compliance Manager (M/V) in Brussels
Regulatory Compliance Manager for Medical Devices
for a medical device manufacturer you will report regularly to the site manager in BE as well as report to the corporate Regulatory Affairs and Vigilance Director based in Paris. You will be responsible for the regulatory compliance
Regarding our class III sterile medical devices ranges.
Tasks and Responsibilities:
· Provide technical documentation for registration of medical devices in countries outside Europe.
· Compilation of variation files and follow-up of variation process with notified body.
· Part of CAPA, non-conformity, risk and change control boards for regulatory field.
· Ensure regulatory compliance for batch release
· Ensure regulatory compliance for quality and technical complaints treatment
· Regulatory survey and gap analysis.
· Part of internal audit team.
· Materio vigilance substitute.
· Scientific background
· Knowledge and experience of MDD 93/42 EC and ISO 13485 and related documents (Med dev).
· Knowledge of Brazilian and Canadian for medical device regulatory requirements is a must.
· Risk analysis process.
· Fluent French and English-speaking and writing skills
· Full time position based in Brussels area with occasional trips to Paris area.
If you think you have the right profile for this position, please apply online on the Kelly jobsite.
For more information, you can contact our office at
02 / 211.08.95
We will be sure to follow up on your application.