Medical Device

7 hours ago

Taipei Taipei City, Taiwan Adecco Full time NT$900,000 - NT$1,200,000 per year

【Client Description】

台灣知名醫療器材品牌製造廠,具備自有開發能力與多元產品線,長期深耕台灣與海外市場,並依據國際法規要求持續更新產品生命週期管理與品質系統。公司具備穩定量產能力、跨國合作經驗,並持續擴大海內外法規與市場佈局。

【Candidate Profile】

  • 3 年以上醫療器材法規事務經驗,熟悉 TFDA 產品管理制度、QSD/QMS 要求,了解不同產品類別審查流程。
  • 具備 ISO 13485、ISO 14971 基礎知識,能理解 QMS 與技術文件之間的關聯。
  • 熟悉醫療器材技術文件架構(含風險管理、驗證驗證資料、生物相容性、臨床資料、上市後監測)。
  • 可獨立完成法規資料彙整與撰寫,具備跨部門協作能力與文件邏輯整合能力。
  • 英文讀寫能力佳,能閱讀國際法規、標準與審查指南。
  • 具備製造廠背景或新品開發專案協作經驗尤佳。

【Responsibilities】

  • 依據產品類別與市場需求,準備與維護醫療器材技術文件,包含上市前法規申請資料、產品變更文件、上市後監測資料。
  • 協助完成 TFDA 法規申請(如上市前審查、變更申請、品質系統相關要求),確保文件完整性與時效。
  • 依據 ISO 13485 與適用法規要求,維護法規符合性相關文件,並支援品質系統稽核所需資料。
  • 追蹤與解讀各國法規更新(含 TFDA、EU MDR、US FDA、ASEAN 等),提供內部法規差異分析,確保新產品與量產品符合最新要求。
  • 支援跨部門的新產品開發流程,在設計、驗證、風險管理及臨床評估等面向提供法規觀點。
  • 協助產品註冊進度管理,與研發、品質、供應鏈、業務合作,掌握文件、樣品與測試時程。
  • 協助客戶或海外代理商處理法規需求,包括資料提供、文件核對與合規性說明。

  • Regulatory Consultant/ Trainee Medical Device

    7 hours ago

    Taipei City, Taipei City, Taiwan Vee Care (Asia) Limited Full time $60,000 - $80,000 per year

    Company DescriptionVee Care (Asia) Limited is a global medical device consulting firm specializing in device registration, technical documetation, quality system, compliance and market access solution.Our CustomersOur customer include Apple, Merit, Masimo, Echnous, Lowenstein, Penumbra, MMI, IBA and Panoptics …etcRole DescriptionsVee Care (Asia) Limited is...

  • Medical Device

    7 hours ago

    Taipei, Taipei City, Taiwan Adecco Full time NT$800,000 - NT$1,400,000 per year

    【Client Description】公司為台灣知名醫療器材設備品牌製造商,具備自有設計、生產與市場推廣能力,產品廣泛應用於醫院與醫事機構。組織重視產品策略與市場洞察,持續投入新技術與國際市場布局,並以完整的產品生命週期管理推動品牌成長。【Candidate Profile】5 至 8

  • Sr Medical Specialist/Medical Supervisor

    2 weeks ago

    Taipei, Taipei City, Taiwan Novo Nordisk Full time $60,000 - $120,000 per year

    Job Title: Senior Medical Specialist, Medical SupervisorLocation: TaichungCompany: Novo NordiskJob Summary:We are seeking a passionate and results-driven Medical Representative to join our dynamic team. This role is responsible for comprehensive territory management, including product listing, scientific communication, and tender protection. You will build...

  • Medical Field Sales 3

    7 hours ago

    Taipei, Taipei City, Taiwan W. L. Gore & Associates Full time $60,000 - $80,000 per year

    About The RoleWe are looking for a Field Sales Associate to join our Medical Product Division Sale Team in Taiwan. In this role, you will be accountable for achieving the sales forecast and provide clinical case support to meet the business needs.ResponsibilitiesDevelop profitable sales opportunities, proactively make sales callsDevelop new business to align...

  • Quality Assurance Specialist

    7 hours ago

    Sindian, New Taipei City, Taiwan Cook Medical Full time $90,000 - $120,000 per year

    The Quality Assurance Specialist is responsible for supporting the implementation and maintenance of the Quality Management System (QMS) in compliance with applicable international standards and regulatory requirements. This role develops, implements, and maintains procedures within the QMS, and ensures it is effectively executed, maintained, and understood...

  • IT - Services Senior Engineer

    7 hours ago

    Taoyuan City, Taoyuan City, Taiwan SHL Medical Full time $90,000 - $120,000 per year

    About SHL MedicalSHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for...

  • LTD Advanced Device Development Engineer

    7 hours ago

    Hsinchu City,, Taiwan Intel Corporation Full time NT$200,000 - NT$250,000 per year

    Job DetailsJob Description:This position is in the Logic Technology Development (LTD) team working in one of the most advanced semiconductor cleanroom facilities in the world. You will be designing, executing, and analyzing experiments necessary to meet engineering specifications for their process.What We OfferWe foster a collaborative, supportive, and...

  • QA - Supplier QA Engineer

    2 weeks ago

    Taoyuan City, Taoyuan City, Taiwan SHL Medical Full time NT$60,000 - NT$120,000 per year

    About SHL MedicalSHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for...

  • Medical Specialist – Hema Onc – North

    2 weeks ago

    Taipei, Taipei City, Taiwan Takeda Full time NT$900,000 - NT$1,200,000 per year

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.Job...

  • MFMG - Molding Engineer

    7 hours ago

    Taoyuan City, Taiwan SHL Medical Full time NT$900,000 - NT$1,200,000 per year

    Company OverviewSHL Medical is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively...