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Job Description
- Responsible for creation and annual update of Clinical evaluation reports(CER) for existing medical devices and for newly released ones.
- Responsible for creation and update of Risk Management report(RMR) and post market surveillance (PMS)for medical devices.
- Creation and review of all IFU included within the medical devices from a medical point of view.
- Coordination with Regulatory Affairs specialists to make sure that all reports are complying with international standards (CE,FDA&Canadian).
- Stay up to date with all new regulations and guidelines and make sure that all reports are updated accordingly.
Job Requirements
- Physician with at least 5 Years practicing experience (Preferably ICU, Anesthesia ,Urology , Nephrology or Intravascular).
- Awareness of research methodology including clinical investigation design and biostatistics information management (e.g. scientific background or librarianship qualification ; experience with relevant databases such as Embase and Medline).
- Professional in medical writing (e.g. medical training and experience in systematic review and clinical data appraisal).
- Experience of using catheters(CVC, Dialysis or Urology) with awareness of the related design , diagnosis , conditions , indications , related risk management , alternatives........etc.
- Excellent Communication Skills.
- Professional with MS Office.
- Solid English Language Proficiency.
