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Experts in Dentistry
YU Soo Hoon, Victoria Frank LEE Kong Fei Jennifer NEO Chiew Lian Kelvin FOONG Weng Chiong Stephen HSU Chin-Ying Clara MOK Yuen Pun Keson TAN Beng Choon Vinicius Rosa Dr. Soh Shean Han Murray Thomson Tong Huei Jinn Savita Hadakar FU Jia Hui ONG Hui Lian, Grace LIM Lum Peng Patrick Finbarr ALLEN Tan Hee Hon Mairaj Ahmed SRIRAM Gopu LEE Yun Hui View MoreVania Miranda
Technical Director and Regulatory Affairs Manager
Ceramed
CeraMed
Portugal
My working experience of 12 years is all in the medical devices industries. Beyond others competences, my working experience includes: • Coordinate QMS assuring compliance according to ISO 9001:2008, ISO 13485:2003 and Medical Devices Directive 2007/47/CE • Elaboration of Medical Devices Technical Files to be submitted to the Notified Body for CE Marking • Conduct Internal Audits • Medical Devices Sterilization Validation according to ISO 11137 • Coordinate Certification Audits with Notified Body • Coordinate Communication with Competent Authorities and Notified Body. I consider myself a dynamic, proactive and motivated person. I can easily adapt to new challenges, including individual and team work. I present excellent English skills both written and spoken, as well as excellent knowledge of computer tools. I am able to embrace a new project, and am available to travel inside and outside my country if necessary.
Medical Devices industry