REGULATORY AFFAIRS SPECIALIST
We have a new vacancy for a Regulatory Affairs Specialist with a major multinational in the Midlands region. Our client are undergoing a site expansion project which will lead to further long term prospects. This is initially a 1 year fixed term contract. Our client are an employer of choice in the region.
Provide support for Regulatory Affairs related issues to ensure compliance with global regulatory requirements & Quality System regulations.
Execute and complete tasks and deliverables for CE marking activities as required according to IVD Directive.
Prepare and maintain Technical Documentation for Irish manufactured products.
Provide update and maintain status of product registrations and notifications.
Provide the required information including legal documentation for country specific Regulatory Affairs contacts to enable and maintain product submissions outside the EU as required.
Provide, as required, regulatory input and approval for changes and classification of changes to Device Master Records, Quality System records, labelling etc.
Perform regulatory risk assessments and provide approval for Customer and Quality Technical Communications.
Conduct business in a manner that will protect human health, safety and the environment by complying with all applicable EHS laws, as well as the Abbott Global & Technical Standards.
Maintain electronic management system.
Education & Experience:
You will have a relevant third level qualification to Degree level with 2-3years experience in Regulatory, Technical or Quality areas within the devices or pharmaceutical industry.
Advanced organizational skills and attention to detail.
The ability to work co-operatively and effectively with others to establish and maintain good working relationships.
The highest levels of integrity in the successful completion of your work.
Excellent Communication Skills
For a confidential discussion and more information on the role, please contact Davin Ferguson