- 工作地点：北京
- 职位：Senior Regulatory Specialist
- 信息来源：中华英才网
说明：
Position: Senior Regulatory Specialist此信息由中华英才网审核并发布（查看原发布网址），应届生求职网转载该信息只是出于传递更多就业招聘信息，促进大学生就业的目的。如您对此转载信息有疑义，请与原信息发布者中华英才网核实，并请同时联系本站处理该转载信息。
Location: Beijing
Reports To: GA & RA Manager
PURPOSE AND MISSION
1. To understand international and Chinese regulation well
2. To register new products and renewal products timely according to Chinese regulation
ACCOUNTABILITIES
Customer Satisfaction
1. Maintain a high-level business relationship with internal and external customers. Improve customer relations by monitoring customer feedback to evaluate the performance
RA projects Management
1. Make the project plan, and try to get the SFDA, CCC and other required certificates as earlier as possible.
2. All timeline of RA projects will be reported in RA monthly report.
Personal quality
1. Understand and keep studying all the new regulations both national and international.
2. To become professional in RA field
Communication
1. Regularly communicate the projects status and key issues with all BU/BGs and internal RA team.
2. Actively communicate with external authorities to understand the new regulation.
Product Knowledge
1. And ongoing development
2. Obtain company product knowledge through classroom or on the job training as required. Global Modality Seminar and product training are required
KNOWLEDGE AND SKILLS
Knowledge:
1. Have experience in regulation field
2. Be familiar with Chinese and international regulation in medical devices
3. Product knowledge
Skills:
1. Good English skill
2. Excellent communication and interpersonal skills
3. Self starter and able to work both autonomously and as part of a team
4. Ability to build strong relationships
5. Demonstrated orientation toward process, process improvement and achievement of standards
KEY RELATIONSHIPS
1. SSD China sales and marketing team
2. BU/BGs Q&R team
3. Major customers, SFDA /CQC/ others authorities
DIMENSIONS
1. The incumbent must be aware of the financial impact of their recommendations and/or project activities.
2. The incumbent should seek opportunities for variable cost reduction (i.e. materials, timeline of testing).
3. Maintain overview of the registration documents
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Two heads are better than one. 三个臭皮匠，顶个诸葛亮。
