长沙招聘

In this role, you have the opportunity to

• Provide appropriate global regulatory strategy and planning for new product introductions and product change; ensure timely and well organized registrations activities; Provide guidance on risk assessment, clinical evaluation and required corrective actions to meet regulatory requirements.
• >
• >You are responsible for
• Responsible for implementing regulatory and roadmaps through understanding the competitive market landscape and product marketing strategy.
• Advice product design teams on regulatory strategy and requirements for specific new products/solutions.
• Responsible for regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance.
• Support development of the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements, and Product registrations.
• Create, review and validate marketing and labeling materials while supporting projects and other key regulatory initiatives
• Develop and facilitate regulatory submissions, for new products/solutions, existing products/solutions.

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, engineer or regulatory affairs;
• Minimum of 5 years’ experience in active medical device regulatory affaire role;
• Be skillful in EU MDD/MDR, FDA and China NMPA registration is required;
• Be familiar with global regulation requirements.

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

·         Require 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 problems solving from RA perspective;

·         Capable of handling pressures during working;

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

·         Strong ability in organizing CFT to finish tasks on time;

·         Willing to take ownership and capable of delivering fast.

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。