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1 Day left CLOSING DATE: 29/02/2016

Thermo Fisher Scientific

Regulatory Analyst

34 Application(s) to date

Undergraduate Degree

Closing Date:: 29/02/2016
Skill:: Science and environment
Region:: Renfrewshire
Salary: £8.25 per hour
Length:: 12 weeks
Ref code: NSWPGFYMCS

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Placement summary

Thermofisher is searching for a talented student to undertake a 12 week Regulatory Analyst role in summer. Their Life Technologies products are shipped and sold to customers globally. The EMEA (Europe, Middle East and Africa) regulatory team assess and approve these products for sale in Europe, India and South Africa; however, there are many other countries within the EMEA region which require regulatory assessment to ensure the company is complying with the specific country legislation, if appropriate. Apply today!

Job description

Project Description

In Vitro Diagnostics (IVDs) provide valuable information regarding a patient’s well-being. Medical decisions can be made based on the use of these products and they play a vital role in human health. Life Technologies products are sold to customers Globally. In order to place IVDs on the open market, the company has to ensure that all regulatory requirements are being adhered to. For example, some countries have specific requirements regarding the language in which labelling and product documents are supplied.

Main Tasks:

Conduct a review of information to ascertain in which countries our products are being sold
Further review this information to establish, of these products, how many and what CE IVDs are being sold in these countries
Complete a review of regulations and country information sheets as available to ensure that all legislative requirements are being adhered to, for example, translation requirements if appropriate
Document any gaps regarding the regulatory requirements we need to assess and close in order to ensure full compliance with legislation in a detailed gap analysis report
Conduct a review of the labelling on the CE IVD products identified against the information detailed on the web site and documentation such as instructions for use to identify and differences
Document any gaps identified with regards to labelling in a detailed gap analysis report

The objectives of this project are:

Ensure the business is in compliance with the appropriate legislation in the countries where our product is being sold
Review and ensure harmonization between product labelling, Agile (our internal system), product documentation (Instructions for Use / Material Safety data Sheets) and the web site.
Implement/initiate changes, as appropriate, to each of the items above where necessary to ensure consistency.

Qualifications

This placement is part of The Scottish Life Sciences Internship Programme. The programme is only open to students in 1st, 2nd, or 3rd year, who are studying an undergraduate Life Science Degree in Scotland. Candidates will be reviewed by their CV only, and can apply for a maximum of three placements. For more information please visit: Programme Overview

Skills / Experience

Essential Skills

Good computer skills, working knowledge of Microsoft Excel / Word

Desirable Skills

Appreciation for what is required to work effectively in a regulatory environment

Benefits

Company benefits

The student will benefit from gaining awareness of global standards relevant to labelling for Life Technologies products. The regulatory department will provide training on our internal system Agile. This is a product lifecycle management software system used globally by a variety of companies, including Life Sciences and Industrial Manufacturing. The regulatory department will provide assistance throughout the project as required.

Placement benefits

By undertaking this project, the student will benefit from gaining exposure to the regulatory requirements required to manufacture and sell CE IVDs in a global environment.

Additional information

Location: Inchinnan

Planned interview date: TBC

Preferred start date: TBC