苏州招聘

Your challenge

• Government relations: Familiar with the officials and understanding their requirements for timely approvals.

• Regulations: In depth-understanding and application of SFDA and CQC regulations and the related regulatory process.

• Technical expertise: Knowledge of process and methods and medical product area such as product specifications, product developments / expansions and product safety.

• Understanding of the IEC and related GB standard for good communications with the BIU and CFDA or CQC testing lab’s engineers.

• Excellent communications skill with internal and external customers.

Duties and responsibilities include:

• Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc.

• Create detailed written regulatory plans that can be used to target domestic and international shipment dates.

• Develop and take the ownership of China CFDA submissions

• Support Key market RA team on global registrations

• Establish active communications with regulatory agencies in China.

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

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

• Communicate application progress to internal stakeholders

• Collaborate with worldwide colleagues regarding license renewals and updates

• Maintain regulatory files and tracking databases as required

Requirements:

• BS in engineering discipline or equivalent education, experience, training.

• At least 5 years regulatory experience in medical device industry.

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

• Strong understanding of China FDA and other major international regulations

• Be able to manage multiple tasks and perform with accuracy and a high attention to detail

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

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

Travel frequency: 25-30%

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。