Senior Global Regulatory Affairs Project Manager (device)
My client is an innovating and dynamic Medical Device company currently expanding their Regulatory Affairs Team.
Due to this growth my client is looking for a Senior Regulatory Affairs Specialist with a global experience to join them in Geneva area.
This position will report to the Regulatory Affairs Head.
- This position will be focused on the registration of Class III medical devices, in particular on US and Asian countries:
– Preparation of registration dossiers (ex : technical documentation, PMA and IDE)
– Manage the follow-up of the registration procedures and preparation of responses to Competent Authorities questions
– Assist the team in the Regulatory evaluation of US changes (Change control)
– Manage the maintenance of registration dossiers (modifications and renewals)
- Define the regulatory strategy in the framework of the development of new products in collaboration with internal departments
- Prepare and support audits conducted by Notified Bodies and Competent Authorities
- Be the regulatory affairs representative in the varied project teams
- Key contact and support for distributeurs
- Follow-up the regulatory monitoring for medical devices
YOUR PROFILE :
- Minimum 5 years experience in a regulatory affairs position for medical devices, preferably in international area
- Be familiar with US FDA regulations
- Must be able to write clearly and strong analytical thinking (ability to compile data and summarize results)
- Excellent knowledge of English language
- Team player and enthusiastic individual, versatile and dynamic
- Team-oriented personality
- Ability to work in a dynamic environment
- A first experience in project management would be a plus
For more details, please contact Marine Dollat at email@example.com