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Senior Medical Affairs

Ameco Medical Industries

5 - 10 years Egypt - Egypt

Any Nationality


, Posted on May 30, 2018 1 Opening

Job Description

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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.


Industry Type : Medical / Healthcare / Diagnostics / Medical Devices
Functional Area : Doctor / Nurse / Paramedics / Hospital Technicians / Medical Research

Desired Candidate Profile

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.

Keywords

Medical writing Anesthesia Nephrology Urology Medical affairs clinical data Medical devices MS Office Risk management Customer Executive

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Ameco Medical Industries

About this Company
Ameco Medical Industries is a medical group dealing in Catheters & Healthcare business since more than 12 years , and is being directed by physicians who had practiced medicine for quite a long time and who have got a high experience in the use of medical catheters.
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Industry:
Medical Devices and Supplies
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