求職服務專線
台北 02-2912-6104 轉 2
   02-7703-3104 轉 2
意見回饋
廠商求才專線
台北 02-2912-6104
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
意見回饋

Regulatory Affairs and Quality Assurance Specialist

  • 全職

Regulatory Affairs and Quality Assurance Specialist ensures product registration based on AOP, and ensures compliance subjected to local regulations so as to monitor the safety and efficacy of medical devices.

What will you do?

This role works in between business and government (Competent Authority) regulations. He/She combines knowledge of science, consolidates legal and business perspectives to ensure compliance for products introduced from manufacturer overseas to Taiwan market and to customers. They are responsible for RA and QA hands-on jobs, including registration dossier compilation, license and labeling management, annual GDP internal audit, CAPA follow-ups, and relevant Quality activities.


How will you get here?

Bachelors degree is required. Graduate degree in Medical, Immunology and/or Microbiology specialty is strongly preferred.
At least three-year work experiences in Medical device RA/QA. Class II product registration and GDP operation are a must, GMP/QMS experience is a plus.
Excellent communication in English.
A team-oriented mindset and the ability to work steadily with a wide range of individuals.
Ability to advise regulatory intelligence and cooperate with various stakeholders at multiple levels of the organization.
A strong disposition for decision making and urgent request taking.
Self-starter, capable of working proactively and in an innovative way.
Knowledge, Skills, Abilities

Demonstrate communication and time management ability to drive project across functional teams and to solve problems.
Authorized to conduct annual GDP Internal Audit and relevant quality activities.
Advise manufacturers on local regulatory requirements and updates.
Review company practices and provide advice on regulatory strategy and GDP compliance.

工作條件

  • 接受身份: 上班族
  • 工作經歷: 三年以上
  • 學歷要求: 高中以上
  • 語文條件: 不拘
  • 其它條件: 未填寫

福利制度

勞保,健保,勞退
團體保險(含配偶及子女)
績效獎金(依照個人及公司績效)
員工體檢
年休假11天(第一年照比例)
週休二日
三節禮金

更新日期:2021-10-06

應徵方式

  • 職務聯絡人: Rain Kuek
  • 聯絡E-Mail: (請利用104履歷表應徵此工作) 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽
  • 它: Interested candidates, please submit a copy of your English resume to the link below.
    https://jobs.thermofisher.com/global/en/job/178914BR/Regulatory-Affairs-and-Quality-Assurance-Specialist

應徵分析

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