北京招聘

Role Overview:

1. Familiar with China NMPA registration regulations as well as China standard/guidance development progress, Support in building a regulatory intelligence network that includes global and local regulatory colleagues

2. Investigate, monitor and analyse regulatory developments and information associated with Smith + Nephew business and feed the requirement into the Smith + Nephew projects to ensure the new regulatory compliance obligations.

3. Draft national/industry standards analysis, communications, comments between standard committee and corporate franchise, R&D

4. Interpret complex data into strategic and actionable recommendations to the team and support the team to assess the regulatory trend and develop future strategies

5. Good documentation management, support in maintaining an effective Regulatory Intelligence database, providing RI services for new development projects and for marketed products regarding regulatory requirements

6. Develop and maintain relationships with China industry and regulatory bodies, with specialized expertise in requirements and trends 　 　

Responsibilities:

1. Provide the regulatory and technical support to the team, cooperate with the team, and push the whole registration process going forward as planed following the SOP requirement. (40 %)

2. Coordinate and guide review of relevant new/draft guidelines/standards by BU including coordination of review of the generated company positions (30%)

3. Develop and maintain good communication with internal and external stakeholders. (20 %)

4. Keep good documentation management for the assigned projects. (10%) 　

Location: Beijing commercial 　

Education: Batchelor and above 　

Licenses/ Certifications: 　

Experience: 5 years+ professional experience in the RA role of medical device industry, with certain experience in R&D would be highly preferred 　

Competences: Knowledge and experience on medical device registration, Self-motivated, open-minded and can work independently under ambiguity 　

Physical Demands: Biomedical Engineering, biochemistry or other related fields.

Excellent English language in both written and oral, Good team player, highly efficient, result driven 　

Travel Requirements: 20–30%

Smith & Nephew is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients.
 
We have leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:
?    Orthopedics Reconstruction - joint replacement systems for knees, hips and shoulders
?    Advanced Wound Management - wound care treatment and prevention products used to treat hard to heal wounds
?    Sports Medicine - minimally invasive surgery of the joint
?    Trauma & Extremities - products that help repair broken bones

We have over 15,000 employees around the world. Annual sales in 2016 were more than $4.6 billion.
We are a constituent of the UK's FTSE100 and our shares are traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NYSE: SNN) .