RA_法规事务专员_北京

Job Description Summary

Responsible for Imported BDI_PI Products Regulatory Affairs

Job Description

KEY RESPONSIBILITIES (主要职责)

• Maintain current NMPA approved certificates, including extension registration, change registration and support BU&RC to resolve post-marketing issues.
• Make charge of new products launch in China, including make strategy, control registration timeline, type test, prepare registration documents, following evaluation and get approval.
• Host regular meeting with WW to get requested documents and update registration status.
• Follow NMPA regulations and analysis impacts to BD or responsible products. Other affairs within the team.

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• Medical/Pharmacy background, relevant experience on regulatory affairs
• Bachelor degree or above
• At least 2 years of regulatory affairs experience
• Proficient in spoken and written English and Chinese
• Ability to work independently and experience in a team on multiple projects Excellent interpersonal and communication skills

• Medical device company working experience
• Overseas education background