Policy and Intelligence Assistant Manager

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Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Product Submissions and Registration
Job Category:
Professional
All Job Posting Locations:
Beijing, China
Job Description:

• Share the key information with all internal stakeholders in a timely manner. Professionally interprate and analyze the impacts of new policies and regulations for product full lifecycle. Represent JNJ to join policy-making discussion, and follow-up the development.
• Familiar with policy/ regulation developing procedure and timely involve in the development. Timely capture the new regulation or regulation in drafting stage. Actively contribute to the Medical Device industry associations, especially AdvaMed, Eucomed/COCIR and CAMDI, US & EU Chambers in China; and leading industry discussions on regulations & policies, closely follow-up updates from NMPA.
• Proactively work on China Medical Device regulations and policy, understanding on the relevant overseas regulations (USA, EU, Japan, and IMDRF), provide comprehensive and reasonable regulatory policy proposals, share policies and interpretation with peers and internal/external stakeholders if appropriate.
• Maintain good relationships with internal partners, including global RA, QA, R&D and Manufacture; and connect with medical device healthcare authority, such as NMPA, CMDE, etc. and industry associations such as AdvaMed, EUCCC, etc. Facilitate Policy workshops with NMPA and CMDE, follow up the project proposal completion, working on the process and project finalization's evaluation.
• Lead and delivery internal policy training per needs to improve the registration process. Participate in the review and revision of SOP and/or working guideline, to improve the process efficiency and effectiveness.