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Regulatory Technician
Role Overview
Job Summary:
To provide 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.
To assist with the routine regulatory activities such as document maintenance and product registration requirements for other countries.
Responsibilities and Duties:
Include but are not limited to, the following. Other duties may be assigned by the Senior Regulatory Manager / Regulatory Manager
· Providing regulatory support as necessary
· Updating of technical files
· Compile information to support the registration of products
· Completing regulatory related tasks to support the regulatory function for both new and existing products.
· To ensure that good documentation is maintained for all Quality / Regulatory records.
· Be prepared to carry out other duties as required and participate as part of a team with high standards of work
Company Information
Chalice Medical is a UK-based medical device manufacturer that has been producing single use devices for extra-corporeal bypass surgery since April 2000. In this time, they are proud to have built a reputation as a quality and reliable provider of products and services throughout the UK and Europe.
Their Mission is to make positive advancements in the medical treatment of patients, by providing products and services that improve, support and extend life.
Chalice Medical 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
Responsibilities and Duties:
Include but are not limited to, the following. Other duties may be assigned by the Senior Regulatory Manager / Regulatory Manager
· Providing regulatory support as necessary
· Updating of technical files
· Compile information to support the registration of products
· Completing regulatory related tasks to support the regulatory function for both new and existing products.
· To ensure that good documentation is maintained for all Quality / Regulatory records.
· Be prepared to carry out other duties as required and participate as part of a team with high standards of work
Person Specifications
Personal Attributes/Skills:
· Good team working skills
· Work on own initiative
· Polite, friendly nature
· Commitment and dedication to job duties/ company
· Excellent timekeeping and attendance.
· Be an excellent communicator
· Be extremely professional, customer friendly and amenable
· Approachable and trustworthy
Package
Culture:
Inclusive
Flexible
Agile
Benefits:
Life Assurance
Pension – 5%
Private medical (option to add on any children too)
Company sick leave bonus