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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.
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