面議(經常性薪資達4萬元或以上) 新北市五股區 2年工作經驗 1天前更新
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
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