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 Specialist

  • 全職

The job:
Regulatory Affairs Specialist ensures claim of product license based on AOP, and ensures marketing and legal compliance subjected to Pharmaceutical Affairs Acts so as to monitor the safety and efficacy of medical devices.


What will you do?

Regulatory Affairs Specialists work in between business and government (Competent Authority) regulations. They combine knowledge of science, consolidate legal and business perspectives to ensure products introduced from manufacturer overseas to Taiwan market. They are responsible for RA handling, license management, annual GDP Internal Audit, and relevant quality activities.

How will you get here?


Bachelor’s degree is required. Graduate degree in Immunology and Microbiology is preferred.
At least three-year work experiences in GDP operation and Class II/III product registration are a must, GMP experience is a plus.
Excellent communication in English.
A team-oriented mindset and the ability to work with a wide range of individuals.
Ability to advise regulatory intelligence and cooperatie with various stakeholders at multiple levels of the organization.
A strong disposition for decision making.
Self-starter, capable of working proactively and in an innovative way.

Knowledge, Skills, Abilities
Demonstrate communication and time management ability to drive cross 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 compliance.

Interested candidates please forward your English CV to zoe.chow@thermofisher.com

工作條件

  • 接受身份: 應屆畢業生
  • 工作經歷: 三年以上
  • 學歷要求: 專科 大學
  • 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:2020-12-07

應徵方式

  • 職務聯絡人: Zoe Chow
  • 聯絡E-Mail: 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽

應徵分析

兩週內6-10人應徵
經歷分佈
新鮮人0%
1~3年0%
3~5年14%
5~10年43%
10年以上43%
學歷分佈
碩士及以上71%
大學29%
專科0%
高中0%
高中以下0%
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