*Regulatory Affairs Department
•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.
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
RA specialist or Sr. RA specialist(需有查驗登記經驗)
上班時間: 週一~週五9:00-18:00 .(週休二日)
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