ESSENTIAL DUTIES AND RESPONSIBILITIES
1. Adherence to J&J credo and industry code of conduct, ethics and good regulatory practices, align team members with J&J credo, ensure 100% compliance with local legislation, global regulatory policies, J&J credo.
2. Regulatory Policy
1). Proactively work on the China Medical Device regulations, comparatively study the relevant overseas regulation (USA, EU, Japan, and GHTF), and provide comprehensive and reasonable proposals, and share with all peers and stakeholders if appropriate; focus on Medical Device Provision (Order #276), AE, Registration, Classification, Import, and Clinical study/data;
2). Timely capture the new regulation or regulation in draft within 2 working days since its published, review the translation to ensure its accurate, co-ordinate the discussion and compile the valuable comments and suggestions into a professional J&J position paper;
3). Actively contribute to the Medical Device industry associations, especially the EUCCC;
4). Support industry discussion and workshops on regulations & policies, and closely follow-up updates from SFDA if appropriate.
3. Post market compliance:
1) Support to the handling of post market compliance issue(s), including alignment on communication with SFDA;
2) Monitor and analyze the trends of compliance issues, and improve the related process(es) if appropriate.
4. Process excellence and internal projects
1) Lead and delivery internal training according to Internal training needs.
2) Contribute in RA internal projects.
3) Participate the review and revision of SOP and/or working guideline, to improve the process efficiency and effectiveness.
5. Self development
1) Build up leadership in cross-functional projects and event arrangement;
2) Build up professional by robust understand on China and overseas related regulations.
6. Timely provide regulatory support when required to other team/departments / franchises if needed; fulfil other tasks assigned.

EDUCATION AND EXPERIENCE
1 At least bachelor degree on medical or pharmaceutical or related subjects, master degree is preferred.
2 At least 3-4 years experience in registration regulatory compliance or other related areas in medical device or pharmaceutical industries.

ESSENTIAL SKILLS AND ABILITIES
1 Good learning ability and communication skills;
2 English fluent in reading, writing, oral, listening;
3 Good time management;
4 Familiar with routine operations of computer and software.