Senior Regulatory Affairs

Life Science Recruitment • Galway, County Galway • Posted June 20, 2026

About the Role

Our client a growing medical device organisation currently seeks a Senior Regulatory Affairs Specialist to join their team. The Senior Regulatory Affairs Specialist will be responsible for all regulatory activities including product certification and compliance, and for supporting the ongoing maintenance, audit and continuous improvement of specific elements of the Quality Management System


Role/Responsibilities


  • Manage the regulatory and vigilance process.
  • Prepare regulatory submissions for required markets coordinating input from other stakeholders, tracking and supporting product clearances and certification to completion.
  • Maintain technical files for all cleared products.
  • Support the Senior Quality & Regulatory Manager in managing any required product certification testing.
  • Support the Senior Quality & Regulatory Manager in managing the Risk Management process for all existing and new produ...