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Medical Devices Inspector - Assessment & Surveillance - Medical Devices Department

Closing date for applications: 26/03/2023

Role Summary

Reporting to the Medical Device Inspection Operations Manager, the Medical Devices Inspector will be primarily responsible for:

  • Planning and conducting proactive and reactive inspections of manufacturers and other economic operators as part of the HPRA market surveillance activities for medical devices.

  • Execution of inspections relating to designation of notified bodies for medical devices in Ireland and as part of European joint assessment activities.

  • Execution of inspections arising from the HPRA ongoing surveillance and monitoring programme for Notified Bodies, including observation of audits conducted by the Notified Bodies.

  • Ensuring alignment of inspection activities with other assessment activities across the Medical Devices Department and appropriate interaction with relevant teams and sections in the preparation, conduct and follow up from medical device inspections.

     

    The content below represents a broad guideline for the role of Medical Devices Inspector. Some aspects may be subject to change in accordance with business needs.

     

    The role of a Medical Device Inspector is to identify and evaluate issues at sites inspected, nationally and internationally, that may result in:

  • medical devices being placed on the market that are non-compliant with the requirements of the national legislation (in Ireland), European Community Directives, European Regulations, harmonised standards, and other relevant guidance.

  • onotified bodies, economic operators and other entities that are non-compliant with their obligations and the requirements of the national legislation (in Ireland), European Community Directives, European Regulations, harmonised standards, and relevant guidance.

     

    The sites to be inspected, nationally and internationally, may include;

  • Manufacturers of medical devices

  • Authorised Representatives

  • Contract Sterilisation sites

  • Notified Bodies

  • Distributors & importers of medical devices

  • Critical suppliers and subcontractors of medical device manufacturers

  • Other entities, for example health institutions and laboratories



For more information, please refer to the role profile below. Applications should be submitted via the HPRA Recruitment Portal



Role Profile                               Application form

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