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Senior Regulatory Affairs Specialist

  • 全職

TITLE: Sr. Regulatory Affairs Specialist
REPORTS TO: Regulatory Affairs Manager
LOCATION: Taipei, Taiwan

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit www.thermofisher.com.

THE POSITION:
The Sr. Regulatory Affairs Specialist (based in Taipei, Taiwan) is responsible for managing all aspects of regulated products’ regulatory requirements and deliverables including establishing regulatory strategies, leading product submissions and regulatory compliance activities, and managing tactics for Taiwan Regulatory Affairs in line with corporate and divisional objectives.


Job responsibilities:
This position is based in the Life Science Solutions Group (LSG) Taiwan (TW) office, reporting to Taiwan RA manager, and responsible to:

- Provide cross functional teams with regulatory requirements for regulatory submissions.
- Prepare and submit In-Vitro Diagnostic and Medical Device application submissions to TFDA and lead clinical studies where needed in support of the product filings.
- Ensure regulatory project deadlines and required performance standards are established and met.
- Participate in Animal Health regulatory submissions and/or provide support to the - Animal Health regulatory team if needed for existing or new submission.
- Support the regulatory activities for Cell Therapy and Gene Therapy products in Taiwan.
- Lead Post Market Surveillance of regulated products in Taiwan. Work with cross functional teams, operations and customers to resolve and implement corrective and preventive actions resulting from technical complaints.
- Implement regulatory affairs activities within LSG TFDA GDP QMS.
- Participate in company regulatory/quality audits and assist, as needed.
- Working within Global/APAC LSG Regulatory Affairs organization, provide regulatory and scientific advice to other areas within LSG business.
- Support SG LPD RA and co-ordinate with SDG TW RA for LPD SKUs’ market access in Taiwan.
- Other tasks assigned by line manager.

Minimum Requirements:

- Bachelor's degree or higher degree in Engineering, Sciences or Medicine.
- 5-10 years relevant experience in regulatory affairs related to Medical Device and/or In Vitro Diagnostic Device.
- Regulations, standards and guidelines related to medical devices / in vitro diagnostic in Taiwan, and Global/International regulatory affairs experience and background would be better.
- Strong planning and organizing registration projects
- Skillful in Chinese and English communication, effective written, verbal and presentation skills in the area of regulatory affair applications.
- Business and personal computer hardware and software applications.
- Responding to requests for information and identifying key individuals who need to be involved to get things done.
- Ensuring that information provided is accurate and complete.
- Ability to work effectively and collaboratively, across cultures and functions
- Able to work under pressure and flexible working hours based on business requirements.

工作條件

  • 接受身份: 上班族
  • 工作經歷: 不拘
  • 學歷要求: 大學以上
  • 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:2021-04-06

應徵方式

  • 職務聯絡人: Jolene Yee
  • 聯絡E-Mail: 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽
  • 它: Please apply through Thermo Fisher Scientific career website. Please click on the below job link to submit your English CV/resume.

    https://jobs.thermofisher.com/global/en/job/150346BR/Senior-Regulatory-Affairs-Specialist

應徵分析

兩週內0-5人應徵
經歷分佈
新鮮人0%
1~3年25%
3~5年0%
5~10年0%
10年以上75%
學歷分佈
碩士及以上50%
大學50%
專科0%
高中0%
高中以下0%
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