Looking for a medical practitioner with research experience, for a public body role. This position will have outreach into an EU Commision and Irish Medical Device Sector as a whole.
This individual will be responsible for the approval of medical devices and in vitro diagnostic devices, reporting directly to the Head of Medical Devices.
- 30 days holidays,
- 37-hour working week,
- State pension,
- Mobile phone,
- Excellent training
- Manage a team of internal and external clinicians
- Responsible for the oversight of the clinical assessment of technical documentation (medical device)
- 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 seeking CE mark certification for new application, substantial changes applications and recertification applications in accordance with established procedures, directives, regulations, common specification, standards and guidance documents.
- Where necessary identify and assign clinical device files to appropriately qualified external clinical experts. 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 manufacturers 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.
- Providing clinical support during the medical device audits by competent authorities and European commission.
- A medical practitioner registered with the Irish medical council or equivalent thereof
- Four years post graduate experience in the field of medicine with direct work experience in patient care
- Experience in clinical research or related experience in conducting or assessing pre-clinical or clinical trials
- Comprehensive technical knowledge of the European Directives, European regulations and relevant MEDDEV guidance documents, standards and common specifications in relation to Medical Devices and related technologies desirable
Additional Job Competencies
- Strong project management, communication, interpersonal and team-building skills.
- Exceptional writing and presentation skills.
- Excellent planning, organisational and administrative skills.
- Ability to work on own initiative and as part of a team
If you satisfy the job requirements or even want to chat about the role call Andrius @ 01 4744 692 or email to email@example.com .
Certain aspects of the job essentials might be more important than opthers - so do enquire!
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