Regulatory Affairs Specialist

Job Description
Summary
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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.

Job Description

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.