職缺描述
1. Technical documents writing including -Risk management plan and report -Software validation plan and report -Performance summary report 2. Regulatory affairs of CE including: -administrative and technical documents preparation -solve various problems in whole process -file dossiers with quality management requirement 3.Product registration including new and renewal. 4.Ensure to obtain the regulatory certificates on time for supporting business requirements. 5.Establish good working relationship with officials and experts in authorities, good communication and negotiation with officials and reviewers to guarantee smooth registration
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