苏州招聘

Key responsibilities/essential functions include:
· Actively participate as team member on all assigned new product introductions.
· Create regulatory plan using Regulatory Intelligence and in collaboration with region/country RA to ensure all requirements are met for country submissions.
· Create and file submissions; communicate with authorities regarding these submissions.
· If specific country testing is needed, work with local RA, and arrange for test devices and support as needed.
· Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated products.
· Review changes in existing products to determine need for new/revised submissions or document reason for no submission.
· Facilitate testing and inspection from CFDA, ETL, CSA, TUV and other test labs.
· Assist Operations in ensuring compliance in various QA activities (supplier audits, calibration, defect tracking and completeness of DHR)

Required Qualifications:

1. Bachelor’s Degree & minimum of 3 years’ experience in the medical device industry or with medical product regulatory agencies.
2. Ability to prioritize, plan & evaluate deliverables to established strategic goals.
3. Proven application of analytical skills in a regulatory environment.
4. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English.
5. Demonstrated knowledge & experience conducting scientific, regulatory or business research.
6. Strong problem solving and negotiation skills.
7. Ability to work well independently & in a team setting.
8. Willing to travel up to 10% of time.

Preferred Qualifications:

1. Knowledge of Quality Management Systems (QMS)
2. Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.

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。