Regulatory Affairs Officer – IVD – MedTech – Ref.: CH300420IJ
Our client is the only independent company in Great Britain that for over forty years has sought to provide a simple and total solution for Blood Transfusion professionals across the world, created by biomedical scientists, providing high-quality solutions in over 110 countries. They have achieved ISO 13485 and MDSAP accreditation, with their reagents and diagnostic kits CE Marked.
The role holder will provide regulatory support for launching new IVD/Blood Grouping reagents and along with ensuring continued compliance with current regulatory requirements, helping with Audits and liaising with regulatory authorities, will be involved with the implementation of IVDR 2017/746 requirements.
They would like to hear from anyone with several years’ experience in Regulatory Affairs with an IVD company. Specifically, with working experience of registration of IVD products with EU Competent Authorities & ISO 13485:2016and MDSAP. Additionally, a thorough working knowledge of the IVDD 98/79/EC and knowledge of IVDR 2017/746.
For more information or to express an interest please get in touch with Heather Anderson.