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KEY RESPONSIBILITIES ����؟
1.Lead thepreparation for CE certificate changed from MDD to MDR for CE class IIa activemedical devices.
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2. Evaluate the gapof current technical files and quality management system documents accordingthe MDR requirement and make the project plan and lead the modification.
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3.The leader forthis MDD-MDR change project, work closely with the consultant, notify body,customers and relative departments and ensure to get the MDR certificate asscheduled.
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4.Other tasksassigned by management.
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QUALIFICAITON��Ҫ��
1.College degreeor above in Science and engineering, at least 3 year related working experiencein CE active medical devices registration.
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2.Projectexperience in handling CE medical devices registration independently andfamiliar with ISO 13485 and MDD��
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3. Language skillsFluent in mandarin and English
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4.Excellentcommunication skill and team work spirit
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5.Skilledoperation of Office and relative software
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6.Certifiedauditor ISO13485 is prefer
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7. Have knowledgeof MDR requirements is prefer
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