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Search Results for QA RA Engineer
Job Title. Location Salary Actions

Quality Systems Manager

Role: Quality Systems Manager Location: Newenham Court, Malahide Team: 8 direct reports Hybrid working: 2-3 days a week on site per week Benefits: Competitive salary, 10-15% bonus, pension and full family healthcare Day to day: Manage and maintain the Quality Management System for GDD - ensuring compliance is maintained against ISO 13485: 2016, 21 CFR 820 (and relevant territorial Quality System requirements as they arise within the organization); Monitor the performance of the QMS and implement necessary remediation activities to ensure steady state ...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,
Quality Systems Manager 		EU Not Disclosed

Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Our client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the relevant Regulatory and Notified Bodies. They will also be required to help maintain the Design History Fileof Class III implant. This position offers the opportunity to join in an exciting early stage company developing a...

Location: Dublin,
Senior Regulatory Affairs Specialist 		Dublin Not Disclosed
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QA RA Engineer Career Profile


QA / RA Specialist

A role combining Quality Assurance and Regulatory Affairs, more often found in the Medical Device sector
Main Responsibilities
  • Apply technical solutions to problem solving
  • Apply technical solutions to quality improvement projects
  • Use technical writing skills to clearly describe technical information
    • Analyze customer complaints, identify trends and execute corrective actions
  • Understand standards and their application to medical devices
  • Planning, protocol generation, testing and report generation for medical devices
  • Generation and maintenance of technical files for medical devices
  • Review and update technical files in line with EU medical devices regulatory requirements
  • The use of harmonised standards when compiling a technical file in compliance with the MDD
  • Ensuring that records are filed in accordance with site procedures
  • Supporting R&D

Skills / Experience
  • Engineering / Science qualification
  • 3/4 years experience within R&D / QA/ RA/ Compliance or Validation function in a Medical Device Environment
  • Excellent technical writing experience within a medical device environment
  • 2/3 years experience in Risk, Clinical and Biocompatibility an advantage
  • Fluency in English