1) Under supervision of RA line manager
¬Collaborate with corporate SMEs to prepare, submit, and obtain approval for TFDA Class I, II, and III medical device licenses across multiple business units, and the related site registrations (QSD).
¬Track project status via company systems (e.g., Windchill) and maintain accurate submission and approval records in compliance with Quality Audit requirements.
-Maintain post-market compliance of medical devices, including regulatory changes, renewals, and labeling required.
¬Any other activities as assigned time to time by RA line manager.
2) Builds and maintains positive relationships internally with cross-functional teams and externally with regulatory agencies.
3) Maintain awareness of local regulatory requirements that impact Abbott related to the development and maintenance of products throughout the product life cycle.
4) Completes all required and assigned training prior to performing tasks, in compliance with company policies.
《合作方式》
專案派遣
《工作地點》
台北市中山區民生東路三段
《工作時間》
1、週一至週五 0900-1800
2、週休二日
《薪資與福利》
1、月薪40000-50000（依學經歷核定）
2、任職期滿獎金
3、其他法定福利
歡迎透過IMC網站投遞履歷，或將履歷mail至：herbert.chen@imc.com.tw（信件標題請複製職務名稱）
Familiar with Microsoft computer usages and applications
Good command of written and spoken English
Native-level writing and speaking ability in Mandarin Chinese
Familiar with Taiwan FDA medical device regulations is a plus
Good command of written and spoken English.
Native-level writing and speaking ability in Mandarin Chinese.
Minimum 1 year experience in regulatory affairs is a plus.
Good communication, organization, and coordination skills.
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