A specialist is capable of independently perform below task & participate/execute inter-departmental communication and relevant compliance activities. - Gather regulatory data from NBs and regulatory agencies, and perform assessments on regulatory issues. - Compile, review and submit regulatory applications, and in support of customer product registration. - Responsible for facilities registration with regulatory agencies. - Applicable regulatory Implement/improvement. - Collaborate with other departments to ensure quality and regulatory activities are performed in accordance with Quality policy. - Collaborate with SHL Global RA Team to develop and implement strategies for the regulatory submission and improvement. - Other regulatory tasks. - Assign above job tasks by staffing qualification / personal ability / organization needs. 專員須能獨立執行以下工作任務，並參與/執行跨部門溝通及持續改善活動。 - 追蹤蒐集與分析來自監管機構的法規信息。 - 編輯、確認與遞交送審文件並且支援客戶之產品註冊。 - 主管機關註冊相關事宜。 - 適用法規導入與改善。 - 與相關部門合作確保品質與法規相關活動之合規性。 - 與SHL Global RA Team合作製訂並實施有關法規提交和改進的策略。 - 其他法規事務交辦事項 - 依任用條件/個人能力/組織需求安排以上工作。

瑞健集團(SHL)成立於1989年，目標以西方管理模式在亞洲打造具有國際水準的生產中心。如今，在全球製藥及生物科技領域，SHL已成為藥物輸送系統的OEM/ODM領導製造商，如自動安全注射器。除此之外，SHL還擴展許多產品線，像是軟性結構類醫療產品、醫療氣墊床、醫療床、腦神經手術器具、工業 設備和醫療用吊昇設備等，目標市場為北美、歐洲及亞洲。 SHL (Scandinavian Health Ltd) is currently the world's largest privately-owned designer, developer and manufacturer of advanced drug delivery systems. The organization was established in 1989 by Swedish entrepreneurs Roger Samuelsson and Martin Jelf with the goal of combining world-class manufacturing in Asia with the strengths of Western Management practices. SHL manufactures devices including pen injectors, auto injectors and inhaler systems. We also manufacture a range of other products including pressure mattress systems, patient lifting slings, medical soft goods, beds, neurosurgical devices, catheters and industrial equipment.