苏州招聘

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

You are responsible for

• Mainly support for EU MDR, and may support of China NMPA and US PMA project.

• Responsible for the small countries registration and Notarized document which needed for the registration.

• Support and follow the product testing for the registration.

• Responsible for 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

• Collaborate with worldwide colleagues regarding license renewals and updates

• Maintain regulatory files and tracking databases as required

You are a part of

?Professional Regulatory Team, with around 10+ team peers globally.

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

• BS in science, engineering or clinical.

• Minimum of 2 years’ experience in medical device registration

• Be very familiar with China NMPA, and EU 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。