深圳招聘

PURPOSE
-To understand international and Chinese regulation well.
-To register new products and renewal products timely according to Chinese regulation.

WORKING RELATIONSHIPS工作关系
直接汇报关系的上级职位: Regulatory manager
对外关系: SFDA, Test houses, CQC, SFDA evaluation center,

PRINCIPAL ACCOUNTABILITIES主要工作职责
-register new products according to business plan
-maintain the current licenses and register renewal products in time
-understand and keep studying all the new regulations & standards both national and international
-maintain a good business relationship with internal and external customers
-obtain company product knowledge through classroom or on the job training
-other tasks assigned by team & company

MAJOR CHALLENGES主要挑战
a) Regulations: In depth-understanding and application of SFDA and CQC regulations and the related regulatory process.
b) 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 BU and SFDA or CQC testing lab’s engineers.
c) Personal capability: Good communications skill with internal and external customers.

JOB REQUIREMENTS岗位要求
a) Education学历: bachelor degree
b) Experience工作经验: more than 3 years experiences in RA area, it is better if has the experience in medical device.
c) Travel Frequency出差频率: 25%-50%
d) Competency and Skills 能力和技能:
-Good in written and spoken in English and Mandarin
-Be familiar with China and international regulations
-Good communication and interpersonal skills
-Self starter and able to work both autonomously and as part of a team
-Demonstrated orientation toward process, process improvement and achievement of standards.

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。