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

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

Shift Quality Lead (LOA008182)

Reporting to the Senior Quality Engineer, Shift Quality Lead duties will include active participation in non-conformance investigations and lot disposition decisions, raising of Quality notifications in response to quality non-conformances and ensuring corrections are completed and confirmed on assembly processes. The Shift Quality lead will provide QA support to the shift manager when required. Responsibilities: Monitoring the activities of the Quality Control Lab to ensure optimal efficiency and compliance with all regulatory requirements in the QC lab environment. Prep...

Location: Dublin,
Shift Quality Lead (LOA008182) 		Dublin Not Disclosed
Other Medical Device Jobs
Job Title Location Salary Actions
Quality Manager (Laboratory Diagnostics) Limerick Not Disclosed
Senior Manufacturing Engineer Cork Not Disclosed
R&D Technical Lead Limerick Not Disclosed
Junior Field Service Engineer (Robotic Pharmacy Systems) Dublin Not Disclosed
Quality Engineer Galway Not Disclosed
Principal Systems Engineer Limerick Not Disclosed
Project Engineer Limerick Not Disclosed
Senior Validation Engineer Limerick Not Disclosed
R&D Technical Lead Limerick 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