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Regulatory Specialist (醫療器材法規認證專員)
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企業名
泰博科技股份有限公司
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工作地點
新北市五股區
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薪資
月薪36000~40000元
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工作內容
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
泰博科技股份有限公司-使用1111轉職專區
https://central1111.com.tw/turn/