Medical Officer, Clinical, Medical Devices / Oifigeach Leighis, Cliniciúil, Feistí Leighis
This is a Temporary, Full Time vacancy that will close in {x} days at {xx:xx} BST.
The Vacancy
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 and performance studies for new medical devices and in-vitro diagnostic devices, and safety reports relating to ongoing studies.
- 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, clinical investigation plans and reports, post market clinical follow up data and related documentation as part of notified body oversight and providing clinical advice and input on designation assessments.
- Collaborate with colleagues in other European national competent authorities on issues relating to clinical investigations, performance studies and clinical evaluation, and work with these colleagues in the coordinated assessment of multinational studies.
- Collaborate with colleagues in the HPRA on the assessment of combined studies involving a medical devices/in-vitro diagnostics and medicinal products.
- Contribute to the development of the regulatory guidance documents and standards relating to the clinical investigation and clinical evaluation of medical devices and in-vitro diagnostics at EU and international level, including specialist areas such as devices for unmet need and Breakthrough technology.
- Contributing to scientific opinions on drug-device combination products.
- Maintaining a comprehensive knowledge of scientific and regulatory developments in the EU and communicating these to colleagues and relevant stakeholders, including Department of Health, Health Service Executive, healthcare professionals, patients and the public.
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.
The Company
We are the Health Products Regulatory Authority (HPRA) and we regulate medicines and devices for the benefit of people and animals. We are committed to excellence in health product regulation through science, collaboration and innovation.
Our remit and regulatory functions include human and veterinary medicines, clinical trials, medical devices, controlled drugs, blood and blood components, tissues and cells, and cosmetic products.
The Benefits
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