Closing date for applications: 07/11/2021
ROLE SUMMARY
The in vitro diagnostic medical devices (IVD) Operations Manager will work as part of the Assessment & Surveillance section in the Medical Devices department to assess the technical and regulatory aspects of IVDs. These assessment activities include technical documentation review, vigilance, market surveillance and associated activities, performance evaluations, classification and registration.
Reporting to the Assessment & Surveillance Manager, the IVD Operations Manager will work closely with other group and section managers, within the Medical Devices department to achieve HPRA objectives relating to IVDs. The IVD Operations Manager also maintains effective working relationships with HPRA departments/sections to ensure that tasks are effectively managed and reviewed as appropriate.
The IVD Operations Manager will work to ensure that:
- IVDs are safe and perform as intended without posing undue risk to patients or public health.
- Responses to all issues that arise in relation to IVDs 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 IVDs is carried out effectively and efficiently e.g. issues arising from market surveillance, vigilance cases or vigilance trends / signals as appropriate.
For more information please refer to the role profile below. Applications should be submitted via the HPRA Recruitment Portal
Role Profile Application Form