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Quality & Regulatory Assistant
Role Overview
This role will consist of providing regulatory support to ensure the compliance of new and existing medical products with constantly evolving global legislative requirements, both for the UK and foreign markets. Additionally, assisting with the routine regulatory activities such as document maintenance and product registration requirements for other countries.
Company Information
Our client are a UK-based, leading medical device manufacturer that has been producing single use devices for extra-corporeal bypass surgery for over 20 years. In this time, they are proud to have built a strong reputation as a quality and reliable provider of products and services throughout the UK and Europe.
Their overall mission is to make positive advancements in the medical treatment of patients, by providing products and services that improve, support and extend life.
They currently exports its product range to over 30 countries around the world, via authorised and exclusive distributors. They also have two brand new offices one based in Europe and one in America to support the ever growing demand from their export markets.
Role Requirements
The key responsibilities of the role will include, but are not limited to:
– Providing regulatory support as necessary
– Updating of technical files
– Compiling information to support the registration of products
– Completing regulatory related tasks to support the regulatory function for both new and existing products
– Ensuring that good documentation is maintained for all Quality / Regulatory records
– Being prepared to carry out other duties as required and participate as part of a team with high standards of work
Person Specifications
Our client are looking for:
– Good team working skills
– Ability to work on own initiative
– A polite and friendly nature
– Commitment and dedication to job duties/ company
– Excellent timekeeping and attendance
– Excellent communication skills
– A professional, customer friendly and amenable nature
Package
They are offering:
– An inclusive, flexible and agile culture
– Life Assurance
– Pension – 5%
– Private medical
– Company sick leave bonus