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VP of Quality Assurance and Regulatory Affairs

  • Sector: Medical Devices
  • Contact: Christopher O'Toole
  • Contact Email:
  • Job Ref: 17769

Our Galway based client are looking to hire a VP of QARA to help guide and grow their QARA team as they continue to expand in size of company and product range.

Purpose of the role:

·       To manage and maintain the Quality Management System and the Operational Quality Requirements.

A portion of the responsibilities for this role:

  • Ensuring that processes needed for the Quality Management System are established, implemented and maintained      
  • Ensuring the promotion of awareness of regulatory and customer requirements throughout the organization
  •  Liaison with External parties on matters relating to the Quality Management System
  •  Responsible for the development and implementation of the Corrective and Preventative (CAPA) actions and Audit Systems
  • Management of Design History Files, Technical Files, Design Dossiers; PMA and 510k submissions to Notified Bodies, FDA and Competent Authorities
  • Fostering a strong, interactive and results-driven work environment for the team.
  •  Management experience of medical device QMS activities
  • Clinical Research experience of Class III devices
  • Experience of Regulatory submissions for Class III devices

For a full job description and more information on this role please contact Chris O Toole for a confidential discussion.