Medical Officer - Medical Devices
- Experience Level
- Experienced (non-manager)
Medical Officer, Clinical - Medical Devices
On Behalf of my client, I am recruiting for a Medical Officer – Medical Devices. The successful candidate will report to the Clinical Manager, and be responsible for the provision of clinical support to the Medical Devices department and to other medical devices colleagues across the organisation.
- Providing advice, recommendations and decisions on the assessment of clinical data for medical devices and in-vitro diagnostic devices and assessing the clinical benefit-risk of devices arising from the organisation’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.
- Work with the Clinical Manager to plan and organise work tasks and ensure delivery of work.
- Registerable with the Medical Council in Ireland
- Be a registered medical practitioner with a minimum of two years’ satisfactory service in clinical practice (after becoming entitled to full registration)
- Have excellent planning skills and an ability to adapt to changing conditions and display ability to generate effective and pragmatic solutions to new situations and problems, both strategic and operational
- Have excellent interpersonal and communication skills
- A strong personal work ethos and a proven ability to manage high work throughputs and manage deadlines
Experience with evaluation of medicinal products or medical devices in the industrial, government authority, academic or clinical settings OR knowledge or experience of the use and management of medical devices would be advantageous.