Closing date for applications: 12/01/2020
Reporting to the Clinical Manager, the Medical Officer in the Medical Devices department is responsible for:
- Providing advice, recommendations and decisions relating to the assessment of clinical data for medical devices and in-vitro diagnostic devices and assessing the clinical benefit-risk of devices arising from the HPRA’s medical device regulatory activities, and ensuring appropriate actions are taken.
- Assessment of applications for clinical investigations, safety reports relating to ongoing clinical investigations and compassionate use of medical devices and in-vitro diagnostic devices.
- Assessment of clinical and technical documentation as part of market surveillance and vigilance of medical device and in-vitro diagnostic devices cases.
- Contribution to the development of strategy and proactive market surveillance plans for medical devices based on available data input sources including relevant databases, published literature and epidemiological studies.
- Review of clinical evaluation assessment reports and related documentation as part of notified body oversight and providing clinical advice and input on designation assessments.
- Contributing to scientific opinions on drug-device combination products.
- Effective communication and engagement with colleagues and relevant stakeholders on medical devices and in-vitro diagnostic devices issues, in particular patients and healthcare professionals.
- Development of clinical guidance and capabilities at national and EU level.
- Contribution to EU and international activities relating to clinical data and its assessment.
These activities are undertaken with the aim of ensuring that medical device and in-vitro diagnostic technologies in Ireland and Europe are in compliance with national and European requirements and relevant standards. The section’s overall objective is to help ensure:
- The HPRA’s medical device activities are appropriate, prioritised and relevant to the stakeholders that we serve.
- That medical device and in-vitro diagnostic technologies in Ireland and Europe afford patients and healthcare systems clinical benefits and that associated clinical risks are acceptable.
The role will include the provision of clinical support to the Medical Devices department and to other medical devices colleagues across the organisation.
Applications should be submitted via the HPRA Recruitment Portal.
Role Profile HPRA Recruitment Portal Application form