Closing date for applications: 30/06/2019
Reporting to the Inspection Manager, the Medical Devices Inspector will be primarily responsible for:
- Plan and conduct proactive and reactive audits of manufacturers and other economic operators as part of the HPRA market surveillance activities for medical devices
- Execution of audits relating to designation of notified bodies for medical devices in Ireland and as part of European joint assessment activities.
- Execution of audits arising from the HPRA ongoing surveillance and monitoring programme for Notified Bodies, including observation of audits conducted by the Notified Bodies
- Carrying out audits of custom made, Class I and other medical devices relating to the HPRA registers
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 an Inspector is to identify and evaluate issues at sites audited, in Ireland and abroad, that may result in medical devices non-compliant with the requirements of National legislation (in Ireland), European Community Directives, Regulations and Guidance being place on the Irish or European market. These sites may include;
- Manufacturers of medical devices
- Authorised Representatives
- Contract Sterilisation sites
- Notified Bodies
The Medical Devices Inspector will work closely with colleagues in the Medical Device Department and will maintain effective working relationships with colleagues in all relevant sections and departments of the HPRA, and with stakeholders, to implement the medical device audit requirements in accordance with the HPRA strategic and operational plans. They will ensure that medical devices audit issues that require cross-functional input are effectively communicated, investigated and followed up on.
They will also work closely with members of the Compliance (COM), Human Products Authorisation & Registration (HPAR) and Human Products Monitoring (HPM) departments.
The role involves auditing, reporting and forming conclusions in respect of the compliance in relation to the medical device activities under review. The Inspector provides support to the enforcement and execution of national regulations in relation to medical devices.
Role Profile Application form