DEION
Serve as the regulatory affairs project manager in Greater China region

RESPONSIBILITIES
· Monitor or track CFDA registration projects milestones and deliverables
. Communicate with marketing to support business growth by align RA strategy with China marketing strategy
. Maintain an overview of China Market Clearance and ensure the accuracy of the data in MCM system
. Analyze RA projects performance and lead process improvement projects with RA team
· Confer with pre-market RA & other stakeholders to address identified issues and solve problems
· Proactively monitor regulatory changes and trends, and communicate to relevant stakeholders
· Assess relevant policies and regulations, analyze the impact on business and coordinate relevant stakeholders to ensure implementation and compliance of identified policies and regulations.
. Organize the call for comments events for policies, regulations and standards, influence the regulatory environment to minimize business impact and promote market access
. Maintain and optimize Greater China Regulations Database

SCOPE OF WORK
· Regulatory affairs project manager in Greater China Region

MINIMUM REQUIREMENTS
· Masers degree or equivalent required
· Minimum of five years experience in project management for regulatory affairs
. English as working language

SKILLS, ABILITIES AND OTHER REQUIREMENTS
· Excellent English language skills.
· Strong project management and organizational skills.
· Strong critical thinking skills.

瓦里安医疗系统公司是全球领先的癌症及其他重大疾病诊断及治疗解决方案的供应商。公司以拯救生命为使命，通过与用户及业界伙伴的紧密合作，每年拯救数十万的生命。瓦里安医疗系统公司致力于提供癌症及其他疾病放射治疗、放射外科、质子治疗和近距离放射治疗设备及相关软件。
　　瓦里安医疗系统公司创立于1948年，是第一家入驻美国加州硅谷的高科技公司。今天，作为美国纽交所上市公司，瓦里安医疗系统公司在美国、欧洲和中国设有生产基地，在全球拥有70多个分支机构。是目前世界上最成功的放疗产品公司。


　　瓦里安从90年代开始进入质子治疗技术的开发和研究。在2009年正式全线进入质子治疗系统及其治疗技术和放疗集成信息化的市场，迅速建立了以超导回旋加速器和笔型束扫描技术为先进技术平台的质子治疗业务，并获得优异的市场认可度及强劲的市场竞争力。
　　瓦里安进入中国市场已有30多年历史并于2007年在北京经济技术开发区建立中国工厂及地区总部，设立了公司在北美地区以外唯一的直线加速器生产基地。