公司人數:50
資本額:20,000,000
地址:台北市大安區新生南路一段103巷13號

洽詢電話:02-27401778 |

公司創建於2000年,執行醫療器材臨床試驗CRO和法規等相關服務,為亞洲區醫材法規服務先驅。目前在北京、台北、新加坡、吉隆坡、馬尼拉、雅加達、香港與大阪設有分公司。每位員工都有完整的訓練,並實際參與自身專才相關的計畫及運作,終可獨立執行業務,並成為專業經理人。Qualtech員工來自世界各地並擁有不同的專業背景如工程、醫療、臨床、生物材料、生產及品質控制等,是個多國多元的職場環境。歡迎各領域的人才踴躍加入我們的行列。

營業項目

[醫療器材註冊 Medical Device Regulatory Submission]
理工科技跨領域團隊,以專業知識協助顧客進行在地上市申請與有效且精準地答辯,並在亞洲各國完成多次高風險與III類醫療器材註冊取得證照
1. 台灣TFDA查驗登記及執照代理人服務
2. 中國CFDA產品註冊及法定代理人服務
3. 新加坡HSA註冊及執照代理人服務
4. 香港MDCO註冊及執照代理人服務
5. 馬來西亞MDA註冊及執照代理人服務
6. 菲律賓PFDA註冊及執照代理人服務
7. 印尼MOH 註冊及執照代理人服務
8. 越南MOH 註冊及執照代理人服務

[醫療器材臨床服務 Medical Device Clinical Trial]
1. 先導性試驗
2. 查驗登記類臨床試驗
3. 上市後臨床試驗
4. 安全性與有效性之研究案

應徵須知

 未來擬進入或對醫療器材產業有興趣者
 投遞履歷時,請填寫清楚您所要應徵職務、學/經歷背景、專長等項目,並附上您的中英履歷及自傳,以利主管初步書面的履歷審核。

薪資福利

[福利優於政府規定]
 享勞保、健保、團保及勞退
 周休二日、優於勞基法的休假制度
 依個人能力經驗提供聚有競爭力的薪酬水平,每年依績效表現,進行薪資調整
 國內外旅遊

[優質化工作環境與氣氛]
 餐費補助,下午茶、點心供應
 慶生餐會、部門聚餐、節日慶祝活動 、社團運動活動
 工作地點位於市區、近捷運忠孝新生站,交通方便

[人性化工作環境]
 就職前的各國醫療法規教育訓練
 國內外全方位職業發展雙通道
 開放型管理模式,挑戰性、有樂趣的工作環境
 國內及國外研習活動,多元化新知識與技術學習



目前共有 7 個職缺類型

求才職稱資格條件工作地點需求人數
Project coordinator for medical device regulatory registration (Japanese)
What you’ll be doing…
 Requesting customers necessary documentation for regulatory submissions, maintain and manage those documents.
 Monitors and maintains projects with internal departments and provide updates to customers.
 Assists with the preparation of regulatory documents for submission to local authority until products are successfully registered.
 Gathering information regarding the requirements and relative procedures for medical device registration within the country.
 Searching and translating regulatory information published in the local authorities.
 Other tasks assigned by superior.

We’d love to meet someone with…
 Preferably Bachelor students or above. Knowledge in medical-related field will be a plus.
 Preferably candidates from Japan, or at least fluent in Japanese.
 Candidates who can speak a Chinese will be a big plus. English is preferable.
 Ability to manage multiple projects, set priorities to meet deadlines.
 Keen attention to details.
 Basic skills in MS Office: Word, PowerPoint, Excel, Outlook.

Internship/Part-time/Full-Time Positions Available!


臺北市
1Fl., No.13, Lane 103, Sec. 1, Sinsheng South Road, Taipei City (100m from MRT Zhongxiao-Xinsheng station)
2
Project coordinator for medical device regulatory registration (German)
What you’ll be doing…
 Gathering information regarding the requirements and relative procedures for foreign investor to set up a company within the country.
 Gathering information regarding the requirements and relative procedures for medical device registration within the country.
 Requesting customers necessary documentation for regulatory submissions, maintain and manage those documents.
 Monitors and maintains projects with internal departments and provide updates to customers.
 Assists with the preparation of regulatory documents for submission to local authority until products are successfully registered.
 Gathering information regarding the requirements and relative procedures for medical device registration within the country.
 Searching and translating regulatory information published in the local authorities.
 Other tasks assigned by superior.

We’d love to meet someone with…
 Preferably Bachelor students or above. Knowledge in medical-related field will be a plus.
 Preferably candidates from Germany, or at least fluent in German.
 Proficiency in English. Candidates who can speak a Chinese will be a big plus.
 Ability to manage multiple projects, set priorities to meet deadlines.
 Keen attention to details.
 Basic skills in MS Office: Word, PowerPoint, Excel, Outlook.

Internship/Part-time/Full-Time Positions Available!


臺北市
1Fl., No.13, Lane 103, Sec. 1, Sinsheng South Road, Taipei City (100m from MRT Zhongxiao-Xinsheng station)
2
醫療器材法規工程師
專業要求:工學院、原子科學院、生命科學院,電機資訊學院等
外語要求:中文,英語 聽、說、讀、寫熟練

崗位職責:
 不同國家的醫療器材查驗登記、資料審核及送件。
 與審查單位保持良好協調和溝通。
 器材有關的法律法規、相關標準與相關報告的閱讀與識別。
 向團隊針對專案提供法規與技術的諮詢和支援。
 定期蒐集最新法規資訊並更新內部法規的資料庫。
 與外部機構保持良好協調和溝通,保證相關業務的順利運作進行。
 其他主管交辦事項。

任職資格:
 工程、機電、醫療器械及相關專業大學以上(含)學歷;
 有器械開發、維修與測試相關工作經驗,接受過檢測或法規培訓的優先考慮;
 熟悉國家註冊的法規與國際標準為優先;
 能夠熟練完成產檢測工作;
 具備良好的專業資料撰寫水準。


臺北市
臺北市大安區新生南路一段103巷13號 (距捷運忠孝新生站100公尺)
6
Global Regulatory Affairs Specialist
What you’ll be doing…
 Oversight of regulatory submissions for assigned projects/countries, which may include completion of submissions or notifications, as required.
 Independently interacts and builds partnerships with competent authorities.
 Ability to read and understand regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.
 Providing advice and support to the project team for regulatory or technical aspects of the projects.
 Investigating proactively and capitalizing regulatory information collected throughout studies and maintain Regulatory database accordingly.
 Other duties as assigned.

We’d love to meet someone with…
 Preferably Bachelor students or above with background in Engineering, Nuclear Science, Life Science or Electrical Engineering & Computer Science.
 Knowledge in medical-related field will be a plus.
 Fluent in English is a must, in other language will be an advantage. Candidates who can speak a Chinese will be a big plus.
 Ability to manage multiple projects, set priorities to meet deadlines.
 Keen attention to details.
 Strong interpersonal skills, in written and oral.
 Basic skills in MS Office: Word, PowerPoint, Excel, Outlook.
 No restriction on Nationality.


臺北市
1Fl., No.13, Lane 103, Sec. 1, Sinsheng South Road, Taipei City (100m from MRT Zhongxiao-Xinsheng station)
6
國際業務工程師
崗位職責:
 提供醫材技術或醫材法規專業知識,拓展潛在客戶的業務締結關係、
 了解客戶的需求與提出的技術問題,給予解決方案及製作報價與合約、
 與客戶談判協議合約內容並完成簽約、
 定期與主管進行業務報告與回報進度、
 紀錄與管理客戶資料、
 從事業務資訊之整理及蒐集、
 其他主管交辦事項。

任職資格:
 工程、管理、法務及相關專業大學以上(含)學歷;
 有醫療相關背景或相關工作經驗者優先考慮;
 有第三外語能力者佳;
 態度正面積極、有責任感、親合力高;
 具有良好的學習能力、問題解決能力、溝通表達能力與抗壓性;


臺北市
臺北市大安區新生南路一段103巷13號 (距捷運忠孝新生站100公尺)
5
Business Development Sales Engineer
What you’ll be doing…
 Able to provide pre-sales technical assistance related to medical devices or regulations to potential clients.
 Able to understand client’s problems and provide the solutions independently.
 Able to convey client’s requirements and to prepare quotation and contract accordingly.
 Able to negotiate contract terms and close sales.
 Report sales motions and make business reports to the management team on a timely basis.
 Maintain relationships with clients and manage/track clients contact record.
 Remains knowledgeable and up-to-date on changes and developments in medical devices industry.

We’d love to meet someone with…
 Bachelor degree or Master degree in Engineering, Nuclear Science, Life Science, Electrical Engineering & Computer Science, Technology Management or equivalent practical experience.
 Experience and familiarity of medical-related field is a huge plus.
 Excellent relationship building skills and communication skills to take an independent stance when interfacing clients.
 Fluent in English is a must, in other language will be an advantage. Candidates who can speak a Chinese is a plus.
 Ability to manage multiple projects, set priorities to meet deadlines.
 Ability to quickly learn, understand, and work with new technologies, regulations and solutions related to medical devices.
 Highly motivated, passionate self-starter, analytical, detail-oriented and operationally-focused.
 No restriction on Nationality.


臺北市
1Fl., No.13, Lane 103, Sec. 1, Sinsheng South Road, Taipei City (100m from MRT Zhongxiao-Xinsheng station)
5
Project coordinator for medical device regulatory registration (Indian)
What you’ll be doing…
 Gathering information regarding the requirements and relative procedures for medical device registration within the country.
 Requesting customers necessary documentation for regulatory submissions, maintain and manage those documents.
 Monitoring and maintaining projects with internal departments and provide updates to customers.
 Assisting with the preparation of regulatory documents for submission to local authority until products are successfully registered.
 Gathering information regarding the requirements and relative procedures for medical device registration within the country.
 Searching and translating regulatory information published in the local authorities.
 Other tasks assigned by superior.

We’d love to meet someone with…
 Preferably Bachelor students or above. Knowledge in medical-related field will be a plus.
 Preferably candidates from India.
 Proficiency in English. Candidates who can speak a Chinese will be a big plus.
 Ability to manage multiple projects, set priorities to meet deadlines.
 Keen attention to details.
 Basic skills in MS Office: Word, PowerPoint, Excel, Outlook.

Internship/Part-time/Full-Time Positions Available!


臺北市
1Fl., No.13, Lane 103, Sec. 1, Sinsheng South Road, Taipei City (100m from MRT Zhongxiao-Xinsheng station)
2