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