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Regulatory Affairs Specialist

4 weeks ago

Longford, Ireland Collins McNicholas Full time

Our client, a global healthcare leader is keen to hire a  Regulatory Affairs Specialist  to join their team on an initial 6month contract. This is a fully on site position and can work from the Sligo or Longford site.

Responsibilities:

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 & Regulation. Prepare and maintain Technical Documentation for Irish manufactured products. Provide update and maintain status of product registrations and notifications. 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. Maintain ETMS To Do training list including those standards, Directives, and Regulations defined as relevant.

Requirements:

You will have a relevant third level qualification to degree level 2-3 years' experience in Regulatory, Technical or Quality areas within the devices or pharmaceutical industry. Advanced organizational skills and attention to detail. IVDR experience would be beneficial. 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.