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Tina Chou
醫材法規人員(Medical Device Regulatory Affair Specialist)
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Tina Chou

醫材法規人員(Medical Device Regulatory Affair Specialist)
您好,我是婉婷,謝謝您撥冗閱讀,希望以下內容能幫助您更認識我。   我畢業於文藻外語學院英文系五專部及二技部,主修英文,副修德文。除了正規語言課程外,我亦有興趣從商,因此選修了國際觀光英文、新聞專題製作、廣告學原理、企業管理、人力資源管理、行銷學等課程,希望自己能夠增強其他領域的知識,以活用在職場。在學期間,課外活動、社團、競賽皆有涉獵並且有豐碩的成果表現。我非常習慣在有限的時間內有效率地完成各項任務。   進入職場後第一份工作即是進入鋼鐵國貿業,將中鋼、中鴻、燁聯、燁輝等鋼鐵產品外銷至東南亞數國、澳洲、日本、大洋洲諸島國。在職6.5年,期間努力不懈地學習並充實了完整的國貿實務經驗。曾接受外貿協會舉辦的貿易經營實務入門班一個月的訓練,也完成1.5年的日文在職進修並考過N3。同時,我亦擔任業務主任的管理職,必須教導訓練新進國貿人員,分派並監督他們的工作情況。   第二份工作則是從事眼科醫材國貿業,代理進口歐美、日本、中國、尼泊爾等眼科醫療器材。除了國貿事務外,我亦負責產品辦證事務,需替國外原廠申請優良進口認證(QSD)與查驗登記進口許可證,讓國外產品可以合法進口。這將近四年來我學習到許多辦證的實務,亦參加了許多次法規研習課程,並藉由在國外原廠與衛福部的居間協調中,對每個上市產品從設計、功用、製程檢驗方式等等都有充足的了解,有利於跟業務部門溝通加強產品的優點與行銷方式。同時我也需將客戶的反饋、問題、客訴反映給國外原廠,協助雙方認清問題所在並提供最佳解決方案。並且每年都有兩次以上的國內展會,我也因此增加了備展、參展、接待外賓等經驗。   第三份工作為擔任成功大學衍生之新創醫材公司的品質法規專員,藉助於我之前辦證的實務經驗,替公司建立並維持ISO13485的運作,目標是未來取得在美國、歐洲、台灣的上市許可。為了對法規建置、法規更新有更深層了解,我在職期間密集受訓,參加了ISO13485、美國FDA法規、內部稽核員訓練、歐洲MDR法規等課程。   目前的工作是擔任澳門商原妙醫學科技有限公司台灣分公司之法規專員,主要為公司代理之國外產品辦理許可證註冊與進口事務。除此之外,也協助研發專案產品之前期法規與競品搜尋與比對分析。   我喜歡從事人與人溝通的工作、接觸不同的國情與文化、幫助人們解決問題並增進生活品質或優化使用體驗。希望能接觸更多不同領域、不同產品的銷售,活絡台灣的商業經濟活動。同時具備了國貿與醫材經驗以及語文能力的我會竭盡所能在受訓後盡快融入貴司的營運體系,幫助貴司研發出更貼近使用者需要的產品並提供更好的服務給客戶,希望有這個機會加入像貴司這麼優秀的團隊,謝謝。
澳門商原妙醫學科技有限公司台灣分公司 (Honest Medical Equipment Macau Co., Ltd. Taiwan Branch)
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文藻外語學院
Tainan, 台灣

Featured Resume

Last updated on Feb 7th 2024

Professional Background

  • Current status
    Unemployed
    Ready to interview
  • Profession
    Trade administration
    Patent Administrator
    Import/Export Specialist
  • Fields
    Medical Devices
    Mining Metals
  • Work experience
    10-15 years (10-15 years relevant)
  • Management
    I've had experience in managing 1-5 people
  • Skills
    International Trade
    ISO 13485:2016
    Medical Device Quality Management System Regulations
    Regulations for Governing the Management of Medical Device
    Medical Device Quality Management System Regulation
  • Languages
    English
    Professional
    Chinese
    Native or Bilingual
    Japanese
    Intermediate
    German
    Beginner
  • Highest level of education
    Bachelor

Job search preferences

  • Desired job type
    Full-time
    Interested in working remotely
  • Desired positions
    Regulatory Affair Specialist
  • Desired work locations
    Tainan City, Taiwan
  • Freelance
    Part-time freelancer

Work Experience

台灣研發中心-醫材法規人員(Medical Device Regulatory Affair Specialist at Taiwan RD center)

Sep 2021 - Aug 2023
2 yrs 0 mos
Tainan City, Taiwan
1. Lead the QSD and registration applications for importing medical devices in Taiwan, and also assist in the regulatory certification of medical devices in many countries. 2. Collection and analysis of regulations and competitive products for R&D project products. 3. Implementation and execution of ISO13485/ISO14971. 4. Collection and analysis of sales market data, 5. Import of medical products.

醫療器材法規認證人員 (Medical Device Regulatory Affair Specialist)

Jan 2020 - Feb 2021
1 yr 2 mos
Tainan, East District, Tainan City, Taiwan
1. Obtain inspection reports on functionality, safety and compliance with relevant regulations for the medical devices. 2. Operate and execute of ISO 13485 and QMS quality systems. 3. Maintain DHF files of medical devices. 4. Raw material procurement, supplier search/selection/management, and inventory management.

國貿人員兼法規專員(International Trade & Regulatory Affair Specialist)

May 2015 - Feb 2019
3 yrs 10 mos
Tainan, East District, Tainan City, Taiwan
1. Purchase to foreign manufacturers and arrange reception when they visit, exhibition planning, etc. 2. Arrange cargo transportation, problem consultation, collect exchange rate and tariff information, carry out cargo loading and delivery, etc. 3. Business promotion of the medical equipment products. 4. Assist the foreign manufacturers in preparing shipping documents,execute import customs declaration procedures, handle bank negotiation, and contact delivery & shipping schedules. 5. Execute procurement process and supplier management to achieve low-cost and high-quality procurement goals. 6. Receiving and inventory of goods. 7. Apply for QSD and registration of importing license to TFDA. 8. Intermediate between foreign manufacturers and customers to coordinate customer complaints, maintenance, feedback,improvement and other matters. 9. Regularly provide performance reports and user status briefings to foreign manufacturers.

業務主任 (Sales Chief)

Mar 2008 - Sep 2014
6 yrs 7 mos
Kaohsiung City, Taiwan
1. Sell steel products to worldwide. 2. Execute administrative logistics work, import and export matters,and client communication matters (including customer complaint handling). 3. Arrange cargo transportation, problem consultation, collect exchange rate and tariff information, carry out cargo loading and delivery, etc. 4. Assist customers to prepare customs declaration documents,implement customs declaration procedures, handle bank negotiation,and contact delivery & shipping schedules. 5. Assist the finance & accounting department to handle reimbursement, ERP input & output operations, and administrative affairs. 6. Training of new employees.

Education

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Bachelor of Arts (BA)
英國語文學系
2005 - 2007
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Associate’s Degree
英國語文學系
2000 - 2005

Licenses & Certifications

初階醫療器材臨床試驗教育訓練課程

財團法人醫藥工業技術發展中心
Credential ID: 藥技醫工證字第11010290240 號
Issued Oct 2021
No Expiration Date
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ISO13485:2016醫療器材品質管理系統內部稽核員訓練之結訓證書

財團法人塑膠工業技術發展中心
Credential ID: 塑訓字第109060528-27號
Issued May 2020
No Expiration Date
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109 年度生技醫藥法規科學訓練課程(2)--醫療器材法規動態與簡介之研習證明

財團法人醫藥品查驗中心
Credential ID: 10905150376
Issued May 2020
No Expiration Date
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Medical Devices (ISO 13485:2016) - Quality Management Systems for Regulatory Compliance Foundation Training Course 醫療器材品質管理系統 (ISO 13485:2016) 基礎課程結訓證書

Hermes Infotech
Credential ID: XqjjPBcgcd
Issued Feb 2020
No Expiration Date
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JLPT N3 TEST 128分通過

日本語能力試驗JLPT
Credential ID: N3A032213T
Issued Jan 2015
No Expiration Date
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Toeic 770分

The TOEIC® Program
Credential ID: 12450820
Expires Feb 2014
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貿易經營實務入門班(三十小時)結業證書

中華民國對外貿易發展協會國際企業人才培訓中心(ITI)
Issued Apr 2009
No Expiration Date