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The role is covered in the following locations: Birmingham, Derby, Liverpool, Leicester, Manchester, Nottingham, Oxford, Sheffield, London

Role Overview

\red5\green99lue193; Do you have knowledge of regulations and compliance within the IV Diagnostics industry?

My client is seeking a Regulatory Technical Specialist to join their Healthcare Diagnostics business in a remote position. As a flexible Regulatory Technical Specialist, you will be working for a facility that manufactures and distributes reagents for in-vitro diagnostic medical devices used in hospitals worldwide to diagnose medical conditions. This is an exciting opportunity to develop your career in Regulatory Affairs.

What will you be doing?
Providing regulatory production support to the site and the Regulatory Affairs Manager
Providing regulatory assessments for design and process changes and communicate them as required
Working with Manufacturing and Technical Operations to identify and prepare regulatory submissions
Providing regulatory support with regards to CE and Annex 2 List B, product registration and registration in line with IVDR requirements

What are my client looking for?
a degree in a scientific disciple
experience in the in vitro diagnostics or pharmaceutical industry
experience working in a GMP environment and with ISO13485
Knowledge of compliance with essential international standards, regulations and directives

If this sounds like an opportunity that you would be interested in please contact tom@zenopa.com or call 01494 818037


11 Aug 2022

Tom Summerbell

Head of Lab Recruitment

tom@zenopa.com 01494 818 037

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Tags

medical pathology    poct    diagnostics    point of care