Key Responsibilities 1. Maintains, sustains and continuously improves the Quality Management System and monitors the performance and health of the Quality Management System through metrics and analytics 2. Responsible for all pre-market registrations / product registration for Taiwan, ensure the products are registered in alignment and compliance with applicable regulations and business objectives 3. Responsible for or together with QA personnel be involved in processes such as maintenance of distribution records, complaint handling, maintenance and service agreements, field actions 4. Work independently and efficiently with regional and global team for Taiwan regulatory needs 5. Ensure accurate and optimal regulatory submissions, and keep a consistent achievement of registration projects in expected schedule 6. Represent the company to interact with regulatory bodies as appropriate; may direct interaction with regulatory agencies on defined matters 7. Monitor regulation developments, update the regulatory requirements on time, and translate regulatory requirements into practical, workable plans 8. Provide other necessary regulatory support to internal departments 9. Leads or compiles all materials required in submissions, license renewal and annual registrations 10. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance 11. Participates and hosts internal and external audits. May serve as liaison between local health authority and the business 12. Maintains a comprehensive audit readiness program to ensure internal and external quality compliance 13. Maintains knowledge of regulatory changes through regulatory standard management process and close cooperation with regulatory affairs 14. Establish local and regional relationships with regulatory affairs, commercial, and logistics team 15. Maintains quality oversight of local distribution and warehouse management process (assessment, qualification, monitoring)

Adecco藝珂是全球最大的國際性人力資源服務公司，藝珂能根據企業的需求，提供最好的專業人才招募及人才派遣等相關人力資源服務，協助企業跨越文化、地域及語言上的限制，招募到最適職及可信任的人才。 藝珂總部設於瑞士，為《財富》（Fortune）排名全球前500大公司，目前已有5,500多家分公司遍佈於超過世界60個主要國家及地區市場，全職員工將近33,000名，每天更有約700,000名的約聘派遣人員為各公司提供服務，而在紐約、巴黎和蘇黎士，藝珂均為公開上市公司。 藝珂台灣分公司則成立於1989年，除了為台灣企業提供人才搜尋的服務外，更為企業的人力資源管理提供一個全方位的服務規劃，並根據專業範疇劃分全新的全球服務領域，得以專注並善加利用產業洞察力、提供作法和全新創舉。 多年來的努力，如今藝珂不僅是台灣最大的人事顧問公司，在台北、新竹、台中、南科、高雄皆有服務據點，深受國內外企業的好評與信賴。其服務市場亦遍及大中華地區與當地分公司密集合作，以最密集的服務網及最完整的服務內容，提供各類產業及大、中、小型企業更多元的人才資源服務，協助企業經營領域的擴展，同時讓求職者有更彈性多元和跨地域的求職空間。 Adecco藝珂根據專業範疇劃分新的六大專業領域，藉由深耕產業知識與人脈，在系統化、專門化的服務之下，進而提升服務能力、滿足客戶需要並嘉惠夥伴。許多求職者面對多變職場的壓力與刺激，採取組合式生涯，藝珂可隨時提供豐富資源和資訊，讓求職者隨時找到最適當的工作。 Adecco Professional Support 六大專業領域 行政管理 (Office) 業務及行銷 (Sales & Marketing) 財務及金融 (Finance & Banking) 工程及科技 (Engineering & Technical) 資訊科技 (Information Technology) 人力資源相關服務 (Human Capital Solutions) 藝珂據點 台北總公司 02-5552-6168 新竹分公司 03-620-1558 台中分公司 04-2301-0781 南科分公司 06-510-6999 高雄分公司 07-226-2060 欲知更多藝珂訊息，請至藝珂官網 www.adecco.com.tw