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*Regulatory Affairs Department
JD:
•Develops and prepare medical device regulatory submissions, license renewal, change and QSD applications.
•Provides input to global regulatory affairs regarding emerging regulation, regulatory pathways, internal procedures, etc.
•Responsible for regulatory planning for product introductions and product changes and assist in maintaining regulatory compliance.
•Supports development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and product registrations.
其他條件:
1.At least 2 years experiences from medical device industry/ regulatory authority is a MUST
2. Bachelor Degree and above in Life-Science or health related field
3. Excellent in both written and spoken English and Chinese
其他人格特質:
1. 需善於溝通與協調，並能獨立完成文件撰寫工作
2. 良好溝通能力及組織能力
3. 對內能團隊合作，有熱誠、認真負責
RA specialist or Sr. RA specialist(需有查驗登記經驗)
工作地點: 台北市民生東路3段
上班時間: 週一~週五9:00-18:00 .(週休二日)
月薪:面議 (依經驗核)
