Regulatory Affairs Manager
Multi-tasking working environment
About Our Client
Our client is a medical devices company with global exposure.
- Support the regulatory strategy pathway for new R&D products.
- Support R&D design process to achieve design history file.
- Prepare documentation for registration of medical device products worldwide.
- Class I to Class IIb Medical Devices submission files Compile documentation for distributors of medical devices
- Prepare documentation for Competent Authorities GMP audits.
- 510k file preparation and submission to FDA Participate in the change management process to evaluate regulatory impact.
- Manage simultaneously multiple regulatory projects with internal and external parties - for labelling, IFUs, device configuration.
The Successful Applicant
- Strong experience in Regulatory Affairs within the Medical Devices industry (approx 7 years)
- International exposure (EU and FDA) Strong autonomy French and English
What's on Offer
Great opportunity to join a global company which is expanding its regulatory affairs activities.