Our client is currently looking for a RA Associate to support the Head of the department.
- This position will be focused on the registration of Class III medical devices, in particular on US and other countries:
1- Preparation of registration dossiers
2- Manage the follow-up of the registration procedures, prepare and liaise with Competent Authorities
3- Assist the team in the Regulatory evaluation of US changes (Change control)
4- Manage the maintenance of registration dossiers (modifications and renewals)
- Define the regulatory strategy in the framework of the development of new products in close collaboration with internal departments
- Prepare and support audits
- Be the regulatory affairs representative in the varied project teams
- Key contact and support for distributors
- Follow-up the regulatory monitoring for medical devices
A minimum of a B.Sc. in a Life sciences subject (Pharmacy, Chemistry, Biology or related discipline).
Post-approval experience with at least one of the main Regulatory authorities is required (FDA, Health Canada, EU).
Minimum experience required 2 years.
An understanding of manufacturing process, in process control, analytical process, stability studies would be beneficial
English and French fluent both oral and writtenEffective organisational/project management skills.
Demonstrable aptitude for IT packages such as Word, Excel, Access & PowerPoint.
Experience of database design/programming languages would be desirable