RA - (Senior) Specialist

Taoyuan, Taiwan

Full-time Mid senior level

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.

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。

【Job Overview】

The Regulatory Affairs Specialist is responsible to independently perform the regulatory affairs relevant tasks and participate/execute inter-departmental communication and relevant compliance activities.

法規專員負責獨立執行與法規事務相關的工作，並參與/執行部門間的溝通及相關的合規活動。

【Responsibilities】

Monitor Regulatory Compliance: Ensure that all materials used in production comply with relevant local, national, and international regulations
Material Evaluation and Approval: Review and approve materials used in manufacturing, including raw materials, packaging materials, and intermediates, ensuring they meet safety, quality, and regulatory requirements.
Develop SOPs: Create, revise, and maintain Standard Operating Procedures (SOPs) related to the handling, use, storage, and disposal of materials, ensuring compliance with industry regulations and internal standards.
Regulatory Documentation: Prepare, update, and maintain documentation to demonstrate compliance with regulatory requirements
Collaborate with SHL Global RA Team to develop and implement strategies for the regulatory submission and improvement.
Assign above job tasks by staffing qualification / personal ability / organization needs.
監控法規遵循：確保所有生產材料符合當地、國家及國際相關法規的要求。
材料評估與核准：審查並核准用於製造的材料，包括原材料、包裝材料及中間產品，確保其符合安全、品質及法規要求。
制定SOP：建立、修訂及維護與材料處理、使用、儲存及廢棄相關的標準作業程序（SOP），確保遵循行業法規及內部標準。
法規文件管理：準備、更新及維護文件，以證明符合法規要求。
與SHL全球法規事務團隊協作：共同制定及執行法規提交與改進的策略。
依人員資格/能力/組織需求分派上述工作任務。