科林儀器股份有限公司
【醫材法規專員】Regulatory Affairs Specialist
9/24 Updated
Array
English Required
Full-time
Mid to Senior Level
English RequiredSalary & Location
Salary negotiable
(Regular monthly salary of NT$40,000 or above)
新北市中和區
Required
Language Requirements
English
聽/精通、說/精通、讀/精通、寫/精通
Work Experience
2年以上
Job Description
Why We Have This Role
The Regulatory Affairs Specialist is a crucial role at Clinico, responsible for ensuring that our products and operations comply with all relevant regulations and standards. This position is essential for navigating the complex regulatory landscape, facilitating product approvals, and maintaining ongoing compliance to support Clinico’s commitment to innovation, integrity, quality, collaboration, and sustainability.
醫材法規專員在科林內部擔任關鍵角色，負責確保我們的產品和運營符合所有相關法規和標準。此職位對於在複雜的法規環境中進行有效導航、促進產品批准和維持持續合規至關重要，以支持科林對創新、誠信、品質、合作和可持續性的承諾。
How You'll Find Success
Success in this role will be determined by your ability to effectively manage regulatory submissions, maintain up-to-date knowledge of relevant regulations, and ensure timely approvals and compliance. You will need to demonstrate strong attention to detail, exceptional organizational skills, and the ability to communicate effectively with regulatory bodies and internal stakeholders.
在這個職位中成功的關鍵在於你能夠有效管理法規提交，保持對相關法規的最新了解，並確保及時獲得批准和維持合規。你需要展現出對細節的高度關注、卓越的組織能力，以及與法規機構和內部利益相關者有效溝通的能力
How You'll Grow
In this position, you will have the opportunity to develop deep expertise in regulatory affairs and enhance your understanding of industry regulations and compliance processes. Working with a dynamic team, you will gain valuable experience in navigating complex regulatory environments and contribute to the successful launch and maintenance of Clinico’s products.
在這個職位上，你將有機會深化在法規事務領域的專業知識，並提升對行業法規和合規流程的理解。與充滿活力的團隊合作，你將獲得在複雜法規環境中導航的寶貴經驗，並為科林產品的成功推出和維護做出貢獻。
Things You Will Do
1.Regulatory Approval and Documentation:Handle the submission, approval, and related modifications (e.g., changes, extensions, updates) for medical devices in Taiwan and Mainland China.
2.Regulatory Compliance Updates:Stay informed about new or updated regulations and provide necessary information to relevant departments.
3.Support for Clinical Trials and Documentation:Assist other departments with clinical trial applications and changes. Regularly update and maintain regulatory documentation and requirements.
4.Monitoring Global Regulatory Information:Continuously track and review medical regulations across different countries, including the establishment, maintenance, and review of technical documents to ensure compliance with government regulations.
5.Additional RA Projects:Manage other annual regulatory affairs projects as assigned.
1. 負責台灣/大陸醫療器材的送審與核准及相關查驗登記之變更、展延、更新...等。
2. 了解新法規或相關法規的變更，提供相關單位所需之資訊。
3. 提供其他部門協助，如：臨床試驗計畫申請與變更，並定期更新與維護查驗登記相關規定。
4. 定期追蹤各國醫療法規資訊，含：技術資料之建立、維護及審查，確保公司遵循政府法令規定。
5. 其他年度RA專案
What You Should Know About This Team
Our team is young and energetic, dedicated to ensuring that our products and operations meet the highest regulatory standards. At Clinico, we emphasize our core values of innovation, integrity, quality, collaboration, and sustainability in every aspect of our work. Join us to be part of a forward-thinking team committed to navigating the regulatory landscape with excellence and driving success through compliance.
我們的團隊年輕且充滿活力，致力於確保我們的產品和運營達到最高的法規標準。在科林，我們在所有工作層面上都強調創新、誠信、品質、合作和可持續性等核心價值觀。加入我們，成為一個專注於卓越法規導航並通過合規推動成功的前瞻性團隊的一員。
Number of Openings
1~1人
Educational Requirements
大學(學院)以上
Field of Study Requirements
法律相關科系、生物學相關、醫學系相關
Work Schedule
日班
Leave Policy
依公司規定
Job Skills
Inspection of Legal Validity of Various Documents
Inspection of Legal Records and Related Documents
檢驗各項文件之法律效力 檢驗法律紀錄和相關文件
Job Category
Legal Affairs
Compliance Officer
Other Legal Professionals
新北市中和區
其他醫療保健服務業
科林創立於1986年，現已發展為集團的規模，涵蓋B2B和B2C的營運模式，我們致力於鑽研與創新，提供跨越眼科、聽力、睡眠及營養保健等多元領域的綜合性醫療解決方案。我們不斷拓展科技知識與技術的邊界，旨在超越當前醫療保健的局限，創造顯著且永續的價值。深入理解病患的真正需求並提供有效的解決方案進而塑造卓越的健康和生活品質。我們的願景為成為亞太地區引領科技研發的醫療照護公司，通過不斷創新、整合和擴展服務範圍，為更多人和地區提供先進且值得信賴的健康照護。
我們的價值觀：
• 誠信與尊重
• 創新與持續優化
• 品質承諾與客戶導向
• 合作與人才發展
• 社會責任與永續發展
如果你/妳是富有使命感的人
如果你/妳認同社會道德責任
如果你/妳有滿腔的熱血想一展長才
歡迎加入我們!
一起創造一個不一樣的醫療保健市場
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我們的歷史
→亞洲第一家通過ISO 9001認證的醫療儀器代理商
→1999年獲得衛生署生物醫學技術獎----醫療儀器類
→第一家醫療代理商通過ISO 13485醫療器材品質管理系統
→第一家助聽器門市服務通過SGS Qualicert服務驗證
→榮獲:2013年幸福心職場最高榮譽[金心獎]
→榮獲:2014年TTQS銀牌認證
→榮獲:衛生福利部國民健康署頒發:健康職場認證
→榮獲:新北市2020年度促進身心障礙者就業績優單位
→榮獲:公益微電影「老爸幫幫忙」榮獲2020年台灣YouTube最成功廣告影片排行榜
→榮獲:2022年新北企業精典獎「多元服務」獎項肯定
→榮獲:2023年獲業界第一家通過「醫療器材優良運銷準則(GDP)」認證
→榮獲:2024年科林助聽器榮獲經濟部第七屆潛力中堅企業獎
Clinico was founded in 1986 and has now developed into a group that encompasses both B2B and B2C operational models. We are dedicated to research and innovation, providing comprehensive medical solutions across various fields, including ophthalmology, otology, polysomnography and nutritional health. We continuously push the boundaries of technological knowledge and expertise, aiming to transcend the limitations of current healthcare and create significant and sustainable value. By deeply understanding the true needs of patients and offering effective solutions, we strive to shape excellent health and quality of life. Our vision is to become a leading healthcare company in the Asia-Pacific region, pioneering technological research and development. Through continuous innovation, integration, and service expansion, we aim to provide advanced and trustworthy healthcare to more people and regions.
Our values:
• Integrity and Respect
• Innovation and Continuous Improvement
• Quality Commitment and Customer Orientation
• Collaboration and Talent Development
• Social Responsibility and Sustainable Development
Our History
→The first medical instrument agency in Asia to obtain ISO 9001 certification.
→Awarded the Biomedical Technology Award by the Department of Health in 1999 for Medical Instruments.
→The first medical agency to pass the ISO 13485 Medical Device Quality Management System.
→The first hearing aid service center to receive SGS Qualicert Service Certification.
→Honored with the "Gold Heart Award" for Workplace Happiness in 2013.
→Awarded the TTQS Silver Certification in 2014.
→Recognized by the Ministry of Health and Welfare for the Workplace Health Certification.
→Recognized as an outstanding unit for promoting the employment of disabled individuals by New Taipei City in 2020.
→Won the award for the public service microfilm "Dad, Help!" which ranked among Taiwan's most successful YouTube ads in 2020.
→Awarded the "Diverse Services" recognition at the 2022 New Taipei City Business Excellence Awards.
→Became the first in the industry to be certified under the Good Distribution Practice (GDP) for medical devices in 2023.
→In 2024, Clinico Hearing Aids received the Ministry of Economic Affairs' Potential Mid-Sized Enterprise Award.
