職缺描述
1. Technical documents writing / review -Risk management plan and report -Software validation plan and report -Performance summary report 2. Submit applications to the U.S. FDA and Health Canada, and hold online meetings with reviewers if necessary 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
收合內容