Technical Writer/Medical Writer(技術文件寫作專員)

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

※智財工作內容: 

1.專利相關事務（專利檢索、撰寫專利說明書、分析評估、爭議等）  

2.協同研發單位進行專利提案分析，並與研發單位討論專利規劃及佈局 

3.閱讀專利相關文件並整理分析 

5.商標申請、檢索及分析 

※專案工作內容: 

1. 進行新產品市場行銷分析以及開發文件的製作、資料彙整及建檔 

2. 掌握專案進度及問題追蹤  

3. 進行跨部門的協調溝通

1. Technical documents writing including 

-Risk management plan and report 

-Post-Market surveillance plan and report 

-General safety and performance requirements report 

- EC declaration of conformity 

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. ISO 13485、MDSAP、UKCA、Taiwan QMS、Taiwan GDP 

6.Establish good working relationship with officials and experts in authorities, good communication and negotiation with officials and reviewers to guarantee smooth registration