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.
