Regulatory Affairs Specialist

Job ref: 1933

£40-60k pa

Cheddar, Somerset

Product recertification in the field of IVD for EU market. Regulatory Affairs Specialist who supports fully our client on recertification of products from IVDD to IVDR and becomes part of a team of 28 associates around the world.
JOB DESCRIPTION

• 300+ products recertification from IVDD to IVDR
• Creation of CE-mark Technical Documentation Files
• Alignment of all product documentation with IVDR
• Submission of CE-mark Technical Documentation Files for review by client’s associates
• Analysis and review of existing study reports to ensure quality and meeting of requirements for IVDR and Notified Body
• Submission of technical files to Notified Body
• Cooperation with SMEs in R&D, QRC, Clinical Affairs, and other functions to write scientific validity reports, analytical performance reports, clinical performance reports and performance evaluation reports based on new or existing data, as needed by Annex XIII of the IVDR