Under the supervision of the Regulatory Affairs Head, your main tasks will be:
- This position will be focused on the registration of Class III medical devices in US:
- Preparation and writing of registration dossiers (ex : PMA and IDE)
- Manage the follow-up of the registration procedures and preparation of responses to FDA question
- Assist the team in the Regulatory evaluation of US changes (Change control
- Manage the maintenance of US licences (ex: annual report, supplements)
- 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 distributors
- Follow-up the regulatory monitoring for medical devices
Qualifications & Experience
- A minimum of 2 years adequate work experience in international environment in regulatory field
MD or Pharmaceutical
- Experience with US FDA regulations is mandatory, experience with Far East REgulation would be
- Native or near native written and oral English and basic French
- Strong project management skills is an asset.
If you feel the description is matching your profile and expectations, please feel free to send your CV and certificates to firstname.lastname@example.org.
We will be happy to further discuss this opportunity with you.