Medical Devices Inspector, Assessment & Surveillance (Medical Devices)

Closing date for applications: 03/07/2022

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.

 

Key Responsibilities

Strategic Objectives

  • Supporting the Medical Device Inspection Operations Manager to ensure our regulatory activities are centred on scientific & regulatory excellence, are value-driven and optimised to achieve the highest standards of device safety, performance and care for patients and healthcare systems.

  • Working with the Medical Device Inspection Operations Manager to prioritise work objectives and to ensure that the strategic goals and targets of the Medical Devices Department are achieved.

  • Contributing to the formulation and preparation of national / international regulatory policies, guidelines and legislation as deemed appropriate.

  • Participation in external national, European and international initiatives.

  • Contributing to activities to foster innovation of new medical technologies.

  • Working with colleagues to develop regulatory approaches that are suitable, proportionate and adaptive to existing, new and innovative technologies.

For more information please refer to the role profile below. Applications (Application form and CV) should be sent directly to our recruitment inbox jobs@hpra.ie


Role profile                 Application form

 



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