QA/RA Manager | Collins McNicholas

QA/RA Manager

  • Reference: AJ43649
  • Job Type: Permanent
  • Location: Galway, Roscommon, Westmeath
  • Category: Medical Devices

Responsibilities with the QA/RA function


  1. Responsible for compliance of  Medical Devices as per Ireland and European Medical Device Regulations.
  2. Provide documents to  Head Office/Customer as assigned by VP – Regulatory Affairs and Product Development (Corporate)
  3. Proactive Communication to Regulatory Head about change in local regulation/policy that can affect business.
  4. Communicate with all functional groups to ensure awareness of regulatory and quality requirements.
  5. Interpret existing and/or new regulatory requirements/Standards as they relate to company products and ensure timely compliance. 
  6. Responsible for preparation and Updation of Technical Master Files
  7. To solve and reply regulatory query.
  8. To co-ordinate with regulatory agencies for audit and compliance.


  1. To Design, Develop and implement of QMS.
  2. Responsible for designing, updating, approving and implementation SOPs for Roscommon facility.
  3. To Conduct Periodic Self Inspections/Internal Audit and MRM (Management Review Meetings).
  4. To implement,handle and approve NCR, incident, Market Complaint, CAPA and Change control, Deviation, OOT, OOS Management.
  5. To monitor cGMP in line with standard procedure.
  6. To prepare RA, DQ, IQ, OQ &PQ and ensure activities as per defined protocols.
  7. Responsible for facing Regulatory audit and its compliance.
  8. To coordinates with external agencies for calibration and validation activities.
  9. To coordinates with inter department of implementation of QMS effectively.
  10. To approve validation protocol, SMF, VMP, QM and other apex documents.
  11. To approve RM / PM/ FP/ and stability Specification and Method of Analysis.
  12. To conduct Quality Risk Management of equipment, process and system.
  13. To involve in calibration and validation activities of lab instruments and equipments.
  14. Responsible for entire SAP related activities.

For a confidential discussion and a more detailed job description (or more information on the role), please contact Tina Egan on 09064 78104or email

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website

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Tina Egan

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  • Tina Egan
  • Recruitment Consultant
  • 09064 50663
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