法規經理

・Provide strategic regulatory direction and mentorship on programs including the overall regulatory plan, regulatory requirements for clinical studies and marketing approval, development plans and study designs, risk assessments, critical issue management and Health Authority (FDA, TFDA, IRB) interactions.
・Ensure the successful implementation and execution of regulatory plans to support product approval and commercialization.
・Oversee the preparation and submission of documentation to support investigational and marketing registration packages and ensure timelines are met.
・Lead preclinical safety testing project and ensure compliance with all applicable standards for medical electrical equipment and active implantable medical device (IEC 60601-1, IEC 60601-1-2, ISO 14708-3, IEC 62304, IEC 62366, ISO 10993 etc.)

• 職務類別：人資／法務／智財 / 法務／智財主管
• 職務性質：全職
• 工作地點：新竹市新竹市
• 工作時間：日班
• 工作經驗：5年以上
• 學歷要求：碩士
• 薪資：依學經歷、證照核薪(每月經常性薪資達4萬元以上)
• 需求人數：1
• 應徵截止：2026-11-30

資料來源：勞動部勞動力發展署「台灣就業通」（政府資料開放授權條款第1版）