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James Cassidy
Life Science

+353 1 5079250
[email protected]
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Details

Clinical Evaluator


Reference:JCAO1301 Location: Republic of Ireland
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Clinical Data Manager

Our client a European notified body for medical devices wishes to recruit a Clinical Evaluator for the review of medical devices and in vitro diagnostic devices. The Clinical Evaluator reports directly to the Chief clinical evaluator. This is a fantastic opportunity for a medical doctor looking for a career change to move into a fast growing and innovative sector

Role/Responsibilities

  • Responsible for the clinical assessment of technical documentation for Medical devices and In vitro diagnostic devices.
  • Scientifically challenge and evaluate technical documentation pertaining to: preclinical data, clinical data, clinical trial data, post market evaluation data, instructions for use, risk management documentation for Medical devices and In vitro diagnostic devices seeking CE mark certification for new application, substantial changes applications and recertification applications in accordance with established procedures, the medical device & In vitro diagnostic device regulations, common specifications, standards and guidance documents.
  • Where necessary identify and assign clinical device files to appropriately qualified external clinical experts in consultation with the chief clinical evaluator. Advise the external expert of the implications and limitations of their review.
  • Appropriately train external experts in the relevant requirements of the directive, regulations, common specification, standards and guidance documents.
  • Scientifically challenge and evaluate clinical reviews carried out by external clinical experts to ensure device safety and performance have been demonstrated.
  • Ascertain comparability and consistency of the assessment of clinical evaluations conducted by external experts.
  • Be able to make an assessment of the manufacturer’s clinical evaluation and a clinical judgement of the opinion provided by the external clinical expert.
  • Liaise with external clinical experts to ensure project timelines are maintained.
  • Ability to draw up records and reports demonstrating that the relevant conformity assessment activities have been appropriately carried out.
  • Schedule, acknowledge, process and track product applications and submissions in keeping with procedures and lead times.
  • Cooperate with other members of Medical Device team in relation to satisfying EU requirements in relation to the body’s notified body status.
  • Provide support as requested in relation to the management and control of all medical device activities.
  • Assessment of vigilance and safety reports associated with medical devices and associated issues.
  • Assessment of technical reports pertaining to post market surveillance data
  • Representing notified body by attending and presenting at national and international meetings and conferences as required.
  • Providing clinical support during the medical device and In vitro diagnostic device audits by competent authorities and European commission.


Skills/Experience
  • A qualified licenced medical practitioner based in Ireland.
  • A minimum of four years post graduate experience in the field of medicine with direct work experience in patient care.
  • Knowledge of clinical research and experience in assessment and interpretation of conducted clinical trials or clinical data
For further information please contact James Cassidy [email protected] or call in confidence 0860204322