Overview

Reference Number: JO-2106-470454
Regulatory Specialist
Rate: £45,000 – 75,000
Job Type: Permanent
Location: Central London / West End

Job Title: Regulatory Specialist IVD / Senior Regulatory Specialist IVD

Job Location: Homebased

Salary: 45,000 – 75,000 (negotiable depending on experience)

Job Reference: 2106-470454

CPL are now partnering with a global market leader within the IVD space who are looking to grow the team with the hire of a Senior/Regulatory Specialist with a focus on in-vitro diagnostics.

The role will work as part of a global team supporting on IVDR projects, preparing technical files, 510k submissions and global registrations.

Role:

-Support development and implementation of regulatory registration strategy in line with IVDR

-Work closely with product development teams ensuring compliance with IVDR and FDA requirements

-Prepare technical files for CE certifications

-Support with premarket submissions (510k / PMA submissions)

Experience:

-Good understanding of Regulatory Affairs within IVD Medical Devices

-Knowledge of IVDR regulations

-Experience preparing technical files

-Experience with submissions

If you are interested, please apply with an updated version of your CV and I will be in touch to discuss further details.