Role Profile Medical Officer- Medical Devices

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1 Role Profile Medical Officer- Medical Devices ROLE SUMMARY The Medical Officer role will be within the Medical Devices department. Reporting to the Deputy Director Medical Devices, the role of the Medical Officer is the evaluation and regulation of the safety and performance of medical devices in Ireland and the European Union, to provide clinical support to the relevant line managers, and to the Deputy Director of the Medical Device Department on medical device issues. The role will include provision of clinical support across the medical devices teams. The following key activities are indicative of the range of duties to be undertaken by the Medical Officer: o Reviewing the safety and performance of medical devices; analysis of their risk/benefit, in particular from a clinical perspective, and assessment of clinical evaluations of medical devices as well as consideration of the public health consequences of their use o Forming, documenting and reporting on key findings based on critical appraisal of clinical data and making well founded recommendations based on clinical assessment work o Contribution to technical and clinical assessment activities arising during notified body designation and oversight, market surveillance of medical devices and classification and qualification activities o Assessment of vigilance and safety reports associated with medical devices and associated issues o Assessment of applications for clinical investigations of medical devices and contributing to scientific opinions on medicinal substances used in drug-device combination products. o Contributing 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 o Assessment of compliance, technical files, classification files and clinical evaluation files relating to medical devices o Contributing to the collection of data and knowledge on medical device technologies. o Contributing to the development of clinical requirements and specifications for medical devices and relevant clinical guidance o Clinical liaison with Health Product Regulatory Authority (HPRA) colleagues, applicants, regulatory authorities and other relevant bodies, healthcare professionals and the community o Provision of clinical information, advice, and guidance to HPRA colleagues, relevant bodies and individuals o Representing the HPRA on national and international bodies, especially European working groups and other bodies o Participation in joint working and collaborative activities with other European and international regulatory authorities and with the European Commission o Participation at all levels (HPRA, national, European and international) in the development and preparation of legislation, regulatory policies, guidelines, and opinions. This includes particular focus on the clinical implications of policy and other decisions

2 o Support and contribute to the effective and timely implementation of new legislation, policies and best practice guidance documents o Dialogue effectively with the external clinical community and help reinforce mechanisms for effective communication with external stakeholders at national and international level o Participating in medical device audit and inspection activities as required KEY RESPONSIBILITIES Clinical/Operational Objectives o Assessment of applications for clinical investigations of medical devices o Providing advice and undertaking product specific and class related reviews of medical devices including: o Review of clinical evaluation and related documentation on medical devices. o Review of notified body reports on clinical evaluation reviews. o Risk assessment o Review of data inputs and outputs from market surveillance activities. o Assessing vigilance and safety reports and associated corrective actions related and safety communications o Liaison with, and advice to, manufacturers, notified bodies and professional colleagues in order to facilitate these assessment activities o Providing clinical information, advice and guidance to organisations, (such as the Department of Health (DoH), the Irish Blood Transfusion Service (IBTS), the Food Safety Authority of Ireland (FSAI), industry representative bodies etc.}, to healthcare professionals and lay persons o Ensuring knowledge of state-of-the-art technologies through ongoing professional education and review of the published literature o Providing advice and professional expertise to the HPRA's inspectors in the performance of their duties o Participation in the enforcement of regulations governing medicinal products and medical devices o Contributing to the development of national and European legislation on medical devices as required o Contributing to the development of HPRA policy relating to medical device regulation and subsequent implementation of legislation, policy and regulations. o Contributing to the international harmonisation activities relating to medical devices when required o Performing such other duties whether connected with or incidental to the functions of the HPRA or not as the HPRA may reasonably require Quality Management o Assisting the relevant line manager to ensure the effective implementation of the HPRA quality management system o Assisting the relevant line manager to ensure that there are effective mechanisms in place to capture, store and communicate key information, experience and knowledge o Assisting the relevant line manager to ensure that available information and knowledge across the HPRA is effectively used by the section o Assisting the relevant line manager to ensure that section procedures remain up to date with relevant developments in National, European and International regulations, legislation and guides

3 Performance Management o Working with the relevant line manager to promote effective performance within the department o Taking measures to identify and resolve issues impacting performance in the section o Reporting regularly on progress against specified objectives, goals and performance targets Communications/Customer Service o Participation in regular departmental meetings, cross-organisational meetings and HPRA meetings o Attendance at meetings and symposia nationally and abroad and representing the HPRA as appropriate o Conducting clinical liaison with applicants, regulatory authorities, healthcare professionals and other relevant stakeholders o Ensuring effective dialogue with the external clinical community and building mechanisms to support these exchanges and collaborations o Provision of clinical information, advice, and guidance to regulatory authorities, healthcare professionals and other relevant stakeholders o Liaising with officers of the State, other bodies, and industry sections, as appropriate, on human products issues o Providing timely input to the HPRA s newsletter and HPRA web-site as necessary o Execute professional duties in such a manner so as to contribute to the efficiency and effectiveness of the HPRA General o Perform any such other duties as the HPRA may reasonably require QUALIFICATIONS AND EXPERIENCE To be considered for this post, candidates must: o be registered with the Medical Council in Ireland o be a registered medical practitioner with a minimum of two years satisfactory service in clinical practice (after becoming entitled to full registration) o have excellent interpersonal and communication skills o be of good character In addition to this the ideal candidate will also have one or more of the following; o have an additional undergraduate or postgraduate qualification in a relevant scientific discipline o Published research in the academic, clinical or industrial field of medicine o Experience with evaluation of medicinal products or medical devices in the industrial, government authority, academic or clinical situation o 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. o Knowledge or experience of the use and management of medical devices o Experience representing organisations at meetings. o Experience making presentations to conferences/meetings.

4 REMUNERATION Salary: 83,571 per annum (*new entrants - incremental scale). SUPERANNUATION The new Single Public Service Pension Scheme ( Single Scheme ) commenced with effect from 1 January All new entrants to pensionable public service employment on or after 1 January 2013 are, in general, members of the Single Scheme. HOURS OF DUTY The hours of duty are fixed by the HPRA from time to time. The current arrangements are Monday- Friday (minimum 37 hours). Appointees are eligible to participate in the flexitime arrangements after a period of six months. DURATION OF POST Duration of Maternity Leave ANNUAL LEAVE Annual leave (exclusive of usual public holidays) is 25 days per annum. DUTIES OF POST The duties set out in the role profile (above) are indicative of responsibilities related to this role. As with all posts, the nature of HPRA business is evolving and flexibility is required in order to adapt to changing business needs. CONFIDENTIALITY AND CONFLICT OF INTEREST Employees are prohibited from having any personal or financial interest in any industry that the HPRA regulates from the date of appointment with the HPRA. The HPRA deals with highly confidential matters including identifiable details pertaining to healthcare professionals, patients and commercially sensitive information. Employees are prohibited from disclosing any information in relation to the business of any person obtained in his/her capacity as an officer of the HPRA.

5 VOLUNTARY HEALTH INSURANCE SCHEME A group scheme operates for those wishing to participate and contributions are deducted from salary. REFERENCES The names and addresses of two referees to whom the applicant is well known but not related must be submitted with the application. Reference may be made to current and former employers without further notification of the applicant. Applicants having any reservations on this matter should so state at time of application. CLOSING DATE The closing date for applications for this post is 5 th April INTERVIEWS Applicants attending for interview may be required to prepare a presentation-details will be notified to applicants who are shortlisted. It is anticipated that interviews for this post will take place on the week beginning 23 rd April Note: The HPRA is not in a position to reimburse expenses incurred by candidates attending for interview. COLLECTIVE AGREEMENT: REDUNDANCY PAYMENTS TO PUBLIC SERVANTS The Department of Public Expenditure and Reform introduced, with effect from 1st June 2012, a Collective Agreement which had been reached between the Department of Public Expenditure and Reform and the Public Services Committee of the ICTU in relation to ex-gratia Redundancy Payments to Public Servants. It is a condition of the Collective Agreement that persons availing of the agreement will not be eligible for re-employment in the public service by any public service body (as defined by the Financial Emergency Measures in the Public Interest Acts ) for a period of 2 years from termination of the employment. Thereafter the consent of the Minister for Public Expenditure and Reform will be required prior to re-employment. People who availed of this scheme and who may be successful in this competition will have to prove their eligibility (expiry of period of non-eligibility) and the Minister s consent will have to be secured prior to employment by any public service body.

6 DECLARATION Applicants will be required to declare whether they have previously availed of a public service scheme of incentivised early retirement and/or the collective agreement outlined above. Applicants will also be required to declare any entitlements to a Public Service pension benefit (in payment or preserved) from any other Public Service employment and/or where they have received a payment-in-lieu in respect of service in any Public Service employment. * Candidates should note that entry will be at the minimum of the scale and the rate of remuneration may be adjusted from time to time in line with Government pay policy..

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