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Regulatory Affairs Manager

飞利浦(中国)投资有限公司 Philips (China) Investment Co.,Ltd. 查看所有职位

苏州-工业园区  |  10年以上经验  |  本科  |  招1人  |  08-06发布

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职位信息

In this role, you have the opportunity to

 

Work for a progressive and dynamic company within the medical device industry in a challenging global regulatory environment, develop and communicate a vision for the RA function to management, including the development of global regulatory strategy in the area of regulatory submission.

 

Be a part of team of build a high growth business that will help improve the lives of millions of patients, while advancing Philips digital transformation journey as a global leader in Health Technology.

 

You are responsible for

 

  • Create regulatory plan using Regulatory Intelligence and in collaboration with region/country RA to ensure all requirements are met for country submissions;

  • Through upfront collaboration with Philips Subject Matter Experts, clearly outline China type testing regulatory requirements and support Type Testing activities to ensure timely execution;

  • Actively participate as a team member on all assigned projects supporting Philips devices;

  • Create and file submissions; Communicate with authorities regarding these submissions;

  • 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 NMPA, ETL, CSA, TUV and other regulatory agencies;

 

You are a part of

 

You are a part of Philips Ultrasound Regulatory Affairs Organization with a global footprint. You will report to China Philips Ultrasound Regulatory Affairs Leader. The Regulatory Affairs team is multicultural and are enthusiastic professionals that work as a team to ensure regulatory compliance.

 

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

 

  • Bachelor’s Degree & minimum of 6 years’ experience in the medical device industry or with medical product regulatory agencies.

  • Significant knowledge of all relevant China regulatory requirements and experience in clearly outlining end to end China Type Testing Strategy, facilitation, and extremely well rounded technical negotiation skill sets are a must have

  • Ability to prioritize, plan & evaluate deliverables to established strategic goals. 

  • Proven application of analytical skills in a regulatory environment.

  • Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English.

  • Demonstrated knowledge & experience conducting scientific, regulatory or business research.

  • Strong problem solving and negotiation skills

  • Ability to work well independently & in a team setting

  • Knowledge of Quality Management Systems (QMS)

  • Demonstrated experience interfacing with key regulatory agencies globally (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL


职能类别:医疗器械注册

联系方式

上班地址:钟园路258号(钟园路凤里街路口)

地图

公司信息

关于我们

荷兰皇家飞利浦公司是一家领先的健康科技公司,致力于在从健康的生活方式及疾病的预防、到诊断、治疗和家庭护理的整个健康关护全程,提高人们的健康水平,并改善医疗效果。飞利浦将凭借先进技术、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。公司目前在诊断影像、图像引导治疗、病人监护、健康信息化以及消费者健康和家庭护理领域处于领导地位。飞利浦公司总部位于荷兰,2016年健康科技业务的销售额达174亿欧元,在全球拥有大约71,000名员工,销售和服务遍布世界100多个国家。更多招聘信息,可登录飞利浦招贤纳士网站: http://www.philips.com.cn/a-w/careers/healthtech.html 或飞利浦中国网站:http://www.philips.com.cn 。


加入我们,改变世界
我们提供的不仅是一份工作,而是一个改善人们生活的机会。

在飞利浦,您每天都会和我们一起,共同创新健康科技和解决方案,积极影响数十亿人的生活。您自己的生活也将从此改变。加入我们,您会发现自己的工作与个人生活息息相关,会获得出乎意料的成就感。


我们为您的职业发展提供无限可能
成为飞利浦的员工,您的人生便将开启无限可能。您的职业生涯可能会有意想不到的改变,您可能会面临意想不到的机会。或者,您可能发现您的工作所带来的意义要远远超出自己的想象。

除了在工作中学习知识外,我们还为您提供针对性的指导和正式培训。欢迎加入飞利浦,探寻您的职业会给生活带来多美好的改变。


您发挥***状态,我们才能成就精彩
飞利浦为您提供一系列福利待遇和健康保障计划,为您的身心健康保驾护航。在这里,您既能发挥***的工作状态,又能更好地规划自己的人生。

我们制定了灵活的工作制度,让您在保持高效的情况下,轻松平衡家庭与工作。我们致力于打造包容的工作环境,能够兼顾团队氛围和个人发展。我们相信,在这样一个良好的工作环境下,您可以充分发挥专长,获得职业和个人的双重成长。
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