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(yè)介紹
瓦里安醫(yī)療系統(tǒng)公司是全球領(lǐng)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(yè)界伙伴的緊密合作，每年拯救數(shù)十萬的生命。瓦里安醫(yī)療系統(tǒng)公司致力于提供癌癥及其他疾病放射治療、放射外科、質(zhì)子治療和近距離放射治療設備及相關(guān)軟件。
瓦里安醫(yī)療系統(tǒng)公司創(chuàng)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(yī)療系統(tǒng)公司在美國、歐洲和中國設有生產(chǎn)基地，在全球擁有70多個分支機構(gòu)。是目前世界上最成功的放療產(chǎn)品公司。
瓦里安從90年代開始進入質(zhì)子治療技術(shù)的開發(fā)和研究。在2009年正式全線進入質(zhì)子治療系統(tǒng)及其治療技術(shù)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(shù)為先進技術(shù)平臺的質(zhì)子治療業(yè)務，并獲得優(yōu)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(jīng)濟技術(shù)開發(fā)區(qū)建立中國工廠及地區(qū)總部，設立了公司在北美地區(qū)以外唯一的直線加速器生產(chǎn)基地。
