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Regulatory Affairs Specialist - Abbott

  • Sector: Science & Pharma
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 22864

Our client, a global healthcare leader based in Sligo is keen to hire a Regulatory Affairs Specialist to join their team on an initial 6month contract.


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.

For more information and a confidential discussion on the role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706717