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 & Quality Assurance Specialist

  • 全職

Primary Function of Position:
Execution of regulatory operations, regulatory registrations/filings, post-market surveillance, QMS, liaison with Corporate & Global RAQA teams, advocacy with government bodies and manufacturer associations across the Country (ie Taiwan). Ensure proper liaison with sales, marketing and service teams as well as all support functions.

Roles & Responsibilities:
• Work closely with business department and related parties within IS, and regulatory agencies to manage product registration process and coordinates activities concerned with the submission and approval for new products and existing market product to government regulatory agencies
• Understand regulatory requirements and medical device regulations
• Spearhead all procedure of product registration and administrative work precisely and efficiently and it includes compiling registration submission, filing documents related and keeping, reports, etc
• Ensures compliance with regulatory requirements for pre-market and post-market activities, and consider its applicable strategy
- Apply for registration and market approval and issuance of license or listing of medical devices
- Apply for alteration of the particulars of registration and market approval or listing
- Apply for extension, replacement, and re-issuance of licenses
- Manage medical device adverse events.
- Manage matters related to medical device safety monitoring.
- Manage documents of sources and flow of medical device products
• Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new medical devices and regulatory support of marketed products.
• Report and provide product registration status and results to her/his supervisor
• Closely monitor and communicate with regulatory agencies to seek resolutions on issues or formal dispute that may arise and manage related RA matters
• Ensure compliance with the relevant local Acts and regulations for packages including Chinese labels and IFU
• Support RA&QA manager to ensure the compliance of QMS per medical device regulations and company standards
• Implement post auditing activities and CAPA follow-up & closure
• Review promotional materials to ensure that regulatory agency requirements are met
• Actively participate in various RA&QA projects internally and externally
• Participate in continuous training programs hold by TFDA. Training hours and categories shall be taken in accordance with Regulations for Management of Medical Devices Technicians.
• Other projects may be assigned as necessary

工作條件

  • 工作經歷: 二年以上
  • 學歷要求: 大學以上
  • 語文條件: 英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
  • 其它條件: Skills, Experience, Education, & Training:
    • Preferred 2 years relevant RA&QA experiences in medical device industry
    • A Bachelor degree, Engineering or Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
    • Knowledgeable for ISO13485 and/or QMS for medical device
    • Internal and external audit experience is plus
    • Orientation for work result details, with emphasis on accuracy and completeness
    • Well-organized & focused. Strategic planning skills
    • Professional communication skills, good interpersonal skills and able to work in cross-functional teams
    • Proven ability to review and translate technical documentation into effective regulatory submissions
    • Passionate and a great sense of responsibility
    • Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
    • Language: Fluent English

  •  
  • 歡迎二度就業

福利制度

Health & Wellness
• 勞保
• 健保
• 團體保險 (涵蓋定期壽險、重大疾病險、傷害險、醫療險、職業災害險、癌症險及海外旅遊平安保險等)
• 員工眷屬及子女也涵括於團體保險,提供部分醫療補助
• 年度健康檢查

Leave Entitlement
• 週休二日
• 優於法令之特休/年假
• 不扣薪病假

Other Benefits
• 三節禮金
• 結婚津貼/生育津貼/生日禮金
• 員工推薦計畫
• 優於法令之退休金計畫

更新日期:2022-01-21

應徵方式

  • 職務聯絡人: 人力資源部
  • 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11-30人應徵
經歷分佈
新鮮人0%
1~3年0%
3~5年14%
5~10年29%
10年以上57%
學歷分佈
碩士及以上67%
大學33%
專科0%
高中0%
高中以下0%
清除

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