職位描述
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.
企業介紹
瓦里安醫療系統公司是全球領先的癌癥及其他重大疾病診斷及治療解決方案的供應商。公司以拯救生命為使命，通過與用戶及業界伙伴的緊密合作，每年拯救數十萬的生命。瓦里安醫療系統公司致力于提供癌癥及其他疾病放射治療、放射外科、質子治療和近距離放射治療設備及相關軟件。
瓦里安醫療系統公司創立于1948年，是第一家入駐美國加州硅谷的高科技公司。今天，作為美國紐交所上市公司，瓦里安醫療系統公司在美國、歐洲和中國設有生產基地，在全球擁有70多個分支機構。是目前世界上最成功的放療產品公司。
瓦里安從90年代開始進入質子治療技術的開發和研究。在2009年正式全線進入質子治療系統及其治療技術和放療集成信息化的市場，迅速建立了以超導回旋加速器和筆型束掃描技術為先進技術平臺的質子治療業務，并獲得優異的市場認可度及強勁的市場競爭力。
瓦里安進入中國市場已有30多年歷史并于2007年在北京經濟技術開發區建立中國工廠及地區總部，設立了公司在北美地區以外唯一的直線加速器生產基地。
