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Regulatory Affairs Specialist

  • Sector: Science & Pharma
  • Contact: Davin Ferguson
  • Contact Email: davin.ferguson@collinsmcnicholas.ie
  • Job Ref: 16917

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.

 

Key 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.

·        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.

 

Key Skills

·        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

davin.ferguson@collinsmcnicholas.ie

071 9140251