长沙招聘

  

In this role, you have the opportunity to

• Ensure timely product registrations, regulatory planning for new product introductions and product changes, guidance on risk assessment, and required corrective actions to meet regulatory requirements. As well as leadership and guidance on global regulatory strategy, such as product registrations, and clinical evaluations.

 

You are responsible for

• Responsible for product China/SGP/Japan registration, change and renew, include type testing, document preparation, submission and review feedback etc.

• Responsible for regulatory planning for new product introductions and product changes and assist in maintaining regulatory compliance

• Review and approve advertising, promotional items and labeling for regulatory compliance

• Participate in and advise cross-functional product team on applicable regulations, requirements and standards;

• Identify potential regulatory approvals risks based on changes in regulations, standards country specific issues or other unique characteristics of the project.

• Collaborate with worldwide colleagues regarding license renewals and updates for other small countries.

• Maintain regulatory files and tracking databases as required

   

   

You are a part of

?Professional Regulatory Team, with around 20+ team peers globally.

 

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

• BS in science, engineering or clinical related discipline.

• Minimum of 5 years’ experience in China medical Class II or Class III device registration, be very familiar with China NMPA requirements(preferably in Class III active device experiences)

• Be familiar with global regulations and have success experiences on high-class device will be plus

• Experience in China local manufactured or local developed products will be a plus

• Proficient in English communication including reading, writing, speaking and listening.

• Requires strong written, oral and interpersonal skills to be able to effectively compose agency submissions, interface interdepartmentally and complete assignments with minimal supervision.

• High efficiency on problem shoveling from RA perspective;

• Capable of handling pressures during working;

• Willing to communicate and cooperate with cross function team members;

 

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。