Our client, a public sector body based in Dublin 2, are currently recruiting for a Medical Officer to join their Medical Devices department. This is a three-year contract opportunity with a salary of €87,602 per annum.
- Support the development of strategic plans within the Clinical section that deliver a patient focused and risk centred system of regulation that emphasizes proactive and preventative measures and that are consistent with those of the Department and the wider organisation.
- Support the Clinical Manager in prioritising work objectives to ensure that the strategic goals and targets of the Medical Devices department are achieved.
- Contribute to the formulation and preparation of national/ international regulatory policies, guidelines and legislation as appropriate.
- Support evolving business needs and strategic requirements of the department in undertaking new areas of technical responsibilities in line with these developments.
- Assist the Clinical Manager in meeting the objectives, goals and targets of your section and the Medical Devices department.
- Assist in the compilation of data for management reports, annual report etc. as required.
- Participate in external, European and international initiatives, as appropriate.
- Contribute to activities to foster innovation of new medical devices technologies.
- Working with the Clinical Manager and other colleagues to develop and promote regulatory approaches that are suitable, proportionate and adaptive to existing, new and innovative technologies.
- Ensure activities and follow up actions are conducted in accordance with appropriate legislation and administrative procedure.
- Provide clinical information, advice and guidance to organisations, (such as the Department of Health (DoH), other organisations relevant to public health, healthcare professionals, patient representative groups and lay persons.
- Ensure knowledge of state-of-the-art technologies through ongoing professional education and review of the published literature.
- Participate in the enforcement of regulations governing medical devices.
- Contribute to the development of national and European legislation on medical devices as required.
- Responsible for the completion of high level complex assessments, formulating recommendations and, decision making relating to clinical aspects of medical devices and in-vitro diagnostic devices.
- Provide advice and expertise and Clinical assessment input through participation, when appropriate, in medical device audits conducted by the Compliance department (including GCP).
- Assess vigilance and safety reports and associated corrective actions related and safety communications, and engage with manufacturers, notified bodies and professional colleagues in order to facilitate these assessment activities.
- Provide Clinical advice and expertise to colleagues in relation to issues relating to medical devices and in-vitro diagnostic devices (including designation and oversight of notified bodies, classification & qualification, scientific advice and combination products and emerging technologies).
- Provide support to the medical device research community in Ireland by engagement in preliminary or pre-submission meetings with researchers and sponsors and by supporting medical device innovation office queries.
- Provide clinical information, advice and guidance to organisations, (such as the Department of Health (DoH), other organisations, healthcare professionals, patient representative groups and lay persons.
- Work with the legal team, and other colleagues, to ensure that market actions on medical devices and in-vitro diagnostic devices are robust, consistent and effective and with due reference to appropriate administrative and legal provisions and procedures.
- Assist the Clinical Manager in ensuring that medical device procedures, guidelines and other quality documentation are in place and that they remain up to date with relevant developments in National, European and International regulations, legislation and guidelines.
- Assist the Clinical Manager in ensuring that there are effective mechanisms in place to capture, store and communicate key information, experience and knowledge. As required, working with others within the section to achieve this objective.
- Work with the Clinical Manager to promote effective performance and achieve performance targets within the team.
- Report regularly on progress against specified objectives, goals and performance targets to the Clinical Manager.
- Participate in activity monitoring and reporting initiatives.
- Attend meetings and symposia nationally and abroad and representing the organisation as appropriate.
- Conduct clinical liaison with applicants, regulatory authorities, healthcare professionals and other relevant stakeholders.
- Ensure effective dialogue with the external clinical community and building mechanisms to support these exchanges and collaborations.
- Work with the other members of the Medical Device department, as appropriate, to ensure that relevant and appropriate information, advice and guidance is being disseminated to stakeholders.
- Liaise with officers of the State, other bodies, and industry representatives, as appropriate, on medical device issues.
- Attend and participate in information days and other educational conferences as deemed appropriate.
- Perform any such other duties as the organisation may reasonably require.
To be considered for this post, candidates must:
- 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
In addition to this the ideal candidate will also have one or more of the following;
- An additional undergraduate or postgraduate qualification in a relevant scientific or public health discipline
- Published research in the academic or clinical field of medicine
- Experience with evaluation of medicinal products or medical devices in the industrial, government authority, academic or clinical settings
- Good understanding of methodology and biostatistics, epidemiology and literature review. Experience or a good understanding of risk-benefit analysis, risk assessment or risk minimisation methodologies
- Knowledge or experience of the use and management of medical devices
- Experience representing organisations at meetings
- Experience making presentations to conferences/meetings