- Excellent opportunity to work for an international molecular diagnostics company
- Excellent opportunity to join a dynamic team, working on exciting IVDR projects
About Our Client
My client is a leading molecular diagnostics company that develops, manufactures, and commercialises molecular diagnostic solutions.
- The maintenance of Technical Documentation Files for company device range in accordance with the requirements of the IVDD 98/79/EC and IVDR (EU) 2017/746 for CE-marking activities.
- Administrate regulatory dossiers to support product license applications, import license and product license maintenance for worldwide Regulatory Authorities.
- Maintain specialist knowledge and tracking of the regulatory requirements within each of operational geographical territories.
- Support for the development of the companies regulatory planning, incorporating strategies for the product range in accordance with global requirements.
- Support product risk management activities and the life-cycle of marketed products.
The Successful Applicant
1-2 years experience in working within Medical Devices (Regulatory Affairs role)
IVD experience would be advantageous
Degree in a life science or equivalent either in genetics or molecular biology and significant experience working within a regulatory affairs arena.
What's on Offer
Competitive package available