长沙招聘

(Sr.)Regulatory Affairs Manager  

 

In this role, you have the opportunity to

 

·         Coordinate & review products registration/approvals and amendments to existing products for market access into the Peoples Republic of China.  Communicate with relevant competent authorities, agents, internal departments to ensure the most efficient path to application approval.

·         Advice MG China and BU teams on the most expedient route to obtain product licenses, and ensure market access strategy is aligned with MG China and BU marketing/sales requirements. 

·         Resolve any conflicts of strategy with marketing/sales strategies and determine the regulatory impact of such strategy on license approval timescales.

 

 

You are responsible for

·         Provide regulatory guidance and strategies for timely CFDA approvals.

·         Ensure that Regulatory Strategy for current and future products in China is established with the local Sales and Marketing teams.

·         Making submission planning activities for new and renewal products in China.

·         Proactively identify and assist team members in resolution of priority conflicts and capacity constraints to ensure that registration plans are managed to successfully meet regulatory commitments and strategic business objectives.

·         Participate in various RA task force activities related to new applications and supplements.

·         Provide guidance to the organization in all phases from product development, through application approval, and post-market activities for China.

·         Act as primary interface with BU regulatory teams providing guidance and communication of established submission processes and standards, in addition to, making RA planning for responsible products.

 

You are a part of

Great china Q&R team

 

To succeed in this role, you should have the following skills and experience

·         Bachelor degree above, major in medical or engineer

·         More than 10 years experiences in international healthcare area, it is better if has the experience in medical device industry.

·         Be familiar  with China and international  regulations on medical devices

·         Good in written and spoken English and Mandarin 

·         Excellent communication and interpersonal skills

·         Good experience for medical devices testing and technological requirement.

 

荷兰皇家飞利浦公司是一家领先的健康科技公司，致力于在从健康生活方式、疾病预防、到诊断、治疗和家庭护理的整个“健康关护全程”，凭借先进的技术、丰富的临床经验和深刻的消费者洞察，不断推出整合的创新解决方案，助力健康医疗系统实现四重目标——提高大众健康水平、提高医护人员满意度、改善患者体验，并降低关护成本。飞利浦的愿景是通过有意义的创新，令世界更健康、更可持续的发展，到2030年每年改善25亿人的生活。

        飞利浦公司总部位于荷兰，2021年销售额达172亿欧元，在全球拥有大约78,000名员工，销售和服务遍布世界100多个国家。公司目前在诊断影像、图像引导治疗、病人监护、医疗信息化以及消费者健康和家庭护理领域处于领导地位。

        在飞利浦，每一个人，都至关重要。这是我们始终坚持的信念。在飞利浦，你将用数字化驱动有意义的创新，积极影响自己与数十亿人的生活，践行改善人类生活的使命。我们全心营造多元包容的工作环境，平等互助的工作氛围，让你的独特之处得到充分尊重和欣赏，鼓励你释放真我，以梦为马，不负韶华。本着 “立足中国，辐射全球” 的理念，我们通过布局广泛的业务线，为你带来广阔的平台、丰富的学习资源、多样的内部发展机会，助你成为具备全球化视野和本土深度的一专多能复合型稀缺人才。

创美好，做真我，迎蜕变。
我们深信每一个你都卓尔不凡, 更期待与志同道合的你笃行致远。