Technology Group Lead, Assessment & Surveillance - Medical Devices

Closing date for applications: 16/04/2019

ROLE SUMMARY

The medical devices technology group leads will work as part of the Assessment & Surveillance section in the Medical Devices department to assess the technical and regulatory aspects of medical devices. These assessment activities include technical documentation review, vigilance, market surveillance and associated activities, clinical investigation, classification, combination products and registration.

Reporting to the Assessment & Surveillance Manager, the Technology Group Lead will work closely with other group and section managers, within the Medical Devices department to achieve HPRA objectives relating to medical devices. The Technology Group Lead also maintains effective working relationships with HPRA  departments/sections, in particular with Compliance colleagues with responsibility for medical device inspections, to ensure that tasks are effectively managed and reviewed as appropriate.

The Technology Group Lead will work to ensure that:

- Medical device technologies are safe and perform as intended without posing undue risk to patients or public health.
- Responses to all issues that arise in relation to medical devices are managed effectively and efficiently and to ensure that appropriate action is taken to minimise the risk to public health and ensure compliance to relevant legislation.
- The assessment of technical data for medical devices is carried out effectively and efficiently e.g. issues arising from market surveillance, vigilance cases or vigilance trends / signals as appropriate. Ensure that specific projects arising from market surveillance, vigilance cases or vigilance trends / signals are carried out as appropriate.
- The HPRA communicates effectively, both internally and externally on medical device issues and provides relevant information on devices and on our activities.

The Technology Group Lead will work with the Assessment & Surveillance Managers to ensure HPRA medical device activities are developed and delivered in a manner that is effective, value driven and focused on patients and the public. The Technology Group Lead will help ensure that these activities are impactful, practical and relevant to the stakeholders that we serve.


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