Senior Regulatory Affairs Specialist
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 strong FDA experience to join them in Geneva area.
This position will report to the Regulatory Affairs Head.
YOUR RESPONSIBILITIES:
- 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 mdollat@axepta.com
