MEDICAL OFFICERDUBLIN SOUTH

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CPL

  • 83 MERRION SQUARE
  • DUBLIN 2
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  • Job reference number:15321057
  • Client ID:RI/JO-1802-402504
  • Posted on:08-FEB-2018
  • Salary:NEGOTIABLE
  • Location:DUBLIN SOUTH
  • Job type:PERMANENT

On behalf of our client we are actively recruiting for the vacancy of Medical Officer. Candidates must be registered a registered practitioner and be registered with the Irish Medical Council.

ROLE SUMMARY

The Medical Officer role will be within the Devices Clinical Assessment, Regulatory and Policy section.

Reporting to the Medical Device Lead/Clinical Assessment & Policy Manager, 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 technical support to the relevant line managers on medical device issues.

The Role:
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

Key Responsibilities;

Technical/Operational Objectives
Assessment of applications for clinical investigations of medical devices.
Assessment of applications for Class III medical devices (i.e. medical devices incorporating an ancillary medicinal product i.e. drug/device combinations)
Providing advice and undertaking product specific and class related reviews of medical devices including:
Review of clinical evaluation and related documentation on medical devices.
Review of notified body reports on clinical evaluation reviews.
Risk assessment
Review of data inputs and outputs from market surveillance activities.
Liaison with, and advice to, manufacturers, notified bodies and professional colleagues in order to facilitate these assessment activities
Providing technical information, advice and guidance to organisations.,
Participation in the enforcement of regulations governing medicinal products and medical devices
Contributing to the development of national and European legislation on medical devices as required
Contributing to the international harmonisation activities relating to medical devices when required

Quality Management
Assisting the relevant line manager to ensure the effective implementation of the quality management system
Assisting the relevant line manager to ensure that there are effective mechanisms in place to capture, store and communicate key information, experience and knowledge
Assisting the relevant line manager to ensure that available information and knowledge across the organisation is effectively used by the section

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;
have an additional undergraduate or postgraduate qualification in a relevant scientific discipline
Published research in the academic, clinical or industrial field of medicine
Experience with evaluation of medicinal products or medical devices in the industrial, government authority, academic or clinical situation
Good understanding of methodology and bio-statistics, 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 o Experience representing organisations at meetings.
Experience making presentations to conferences/meetings.

For further detail or to apply for this role please send CV to tdunne@thornshaw.com or call Tina on+353 1 2784671.
For all vacancies log on to www.thornshaw.com

This job originally appeared on RecruitIreland.com