南京招聘

Role Overview:
1. Responsible for setting up the product registration plan per marketing’s registration request
2. Responsible for managing whole cycle of registrations for Ortho products according to the timeframe of registration plan
3. Responsible for following up type testing, preparing submission documents, communicating with NMPA authority during technical evaluation period, conducting in compliance with local regulatory agency requirements and relevant SOP.
4. Responsible for good documentation management.
5. Responsible for providing regulatory support to relevant department
6. Responsible for establishment of good working relationship with regulatory agencies and GBU supporting team
Responsibilities: (Please specify % amount against each responsibility)
This is very important position to Ortho product registration in China. Under that position, the staff needs to:
1. Set up the registration plan for Ortho products according to marketing launch plan or expiration date of original certificate, keep good communication with supervisor and co-worker, provide monthly update for the projects (15%);
2. Follow up testing and technical review for the registration ( 30%)
3. Cooperate with local marketing and sourcing company, push the whole registration process going forward as planed following the SOP requirement. ( 20 %)
4. Set up good relationship with authority from testing centre and technical evaluation centre. (10 %)
5. Assist Ortho RA manager to proceed initial and renewal registration in China according to the plan to support Ortho business growth in China(10%)
6. Keep good documentation management for the registered products. ( 5%)
7. Provide the regulatory support to other departments in daily work ( 5%)
8. Lead RA project and make sure it’s completed as planning ( 5%)
Location: Beijing/Shanghai commercial
Education: Bachelor and above
Licenses/ Certifications:
Experience: 5+ years registration experience
Competences:
knowledge and experience on medical device registration, Resilience, Agile, communication skill, interpersonal effectiveness, result driven, look into detail, custom focus etc.
Physical Demands:
Medical or biological background, come from science department in a college is preferred.
English communication ability, read, write and speak fluently
Team work spirits
Travel Requirements: 15 %

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) .