RA member and responsible of Design Team for CE mark submissions will be conducted in accordance with MDRInternational implementation of the changes.Working on IMDRF and EMEA countries’ regulations and requirements.Working on international launch of a Class III product.Working on MDR requirements prior to internal implementation periodEC certificate renewal application in accordance with MDDManaging and working on every step of international Registration and Regulatory… Show more RA member and responsible of Design Team for CE mark submissions will be conducted in accordance with MDRInternational implementation of the changes.Working on IMDRF and EMEA countries’ regulations and requirements.Working on international launch of a Class III product.Working on MDR requirements prior to internal implementation periodEC certificate renewal application in accordance with MDDManaging and working on every step of international Registration and Regulatory purposes in LatAm, APAC, EMEA, EU, North America regions (such as submissions, registration renewals)Communication with Notified Bodies, National MoH and Competent Authority, and economic operatorsCreation and revision of the SOPs [Standard Operating Plan] and the Procedures.Internal compliance with standards and guidelines Providing internal consultation concerning standards, regulations, guidelines Show less

-Preparing technical files and documentation for medical devices according to ISO 13485 and CE regulations-Risk management -Clinical data evaluation

- Experienced in preparing technical files and documentation for medical devices according to ISO 13485:2003 and FDA regulations. - Experienced in ISO 9001:2008 Quality Management System, worked for obtaining ISO 9001:2008 Quality Management Certicate for Medical Devices Department. - Experienced in classification of medical devices, usability and FMEA (failure mode effect analysis)

Duties: Planning and practicing the maintenance and calibration of the hospital devices, updating and transferring all hospital medical product data to new medical network