Regulatory Affairs Manager招聘_飞利浦（中国）投资有限公司 Philips (China) Investment Co.,Ltd.最新招聘信息-猎才医药网

职位描述

职位描述： Your challengeAs the incumbent of this Quality & Regulatory (Q&R) role within Philips, your challenge will be to guide and support Business Groups, Markets and enabling functions to always do the right thing. This involves being a confident advisor on approval, regulatory compliance and quality management related topics, in order to achieve timely releases of innovative products that deliver high quality and outstanding reliability to the lives they will improve.The Regulatory Affairs Manager will support regulatory affairs activities at our Philips Business Group Health & Wellness Shanghai Innovation site. The RA Manager will execute activities as defined by the RA Manager and with the local Quality & Regulatory leader; supporting RA operations and administration, systems building, regulatory compliance and global submission activities for all products sold by the Philips Business Group Health & Wellness (Medical Devices, complex Cosmetic Products and Consumer Products).ResponsibilitiesWorking in China support our products brings much fulfillment, as well as unique challenges. As part of our HealthTech – focused company, you will be responsible for successfully dealing with and managing Philips relationships with approval agencies such as the China Food and Drug Administration as well as other product related governmental agencies.Key areas of responsibilities (KARS) for this role include:?Based on business priorities & capabilities, the Regulatory Manager will provide support for licensing, approbations, registrations (new & renewals), CTDs, PIFs, Technical Files, regulatory administration, labeling (under supervision), and other assigned projects.?Support systems development and process improvement activities in Regulatory Affairs activities to improve records transparency-organization, compliance, speed, and collaboration, to assure activities are timely meeting needs of the business.?Support preparation and review of registration packages, submission to partners or Competent Authorities; seeking final approval/clearance for new product introductions into any country required by the business.?Support local China Product Standards development for Business Group Health & Wellness, representing Philips for our products to define standards that our products can meet locally.?Collaborate with other functions including Quality Systems, Development, Marketing, Manufacturing & Testing, and Legal to assure coordinated efforts result in desired schedules and timelines for execution of new and revised existing products delivered to the market.?All Managers will be expected to continue to grow in understanding of the global regulatory frameworks applicable to Business Group Health & Wellness.?Communication is a major part of this position and requires use of multiple means including telephone, face-to-face individually or in meetings, written memoranda, formal plans, electronic mail and formal presentations to a group.Your teamAs a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interfaces with Philips Business Group and Market leadership, and can harness the expertise of five Centers of Excellence (COEs). These 5 COEs specialize in the following capabilities: Regulatory & Clinical Affairs, Supplier Quality, Quality Management System, Quality Assurance & Engineering, and Compliance & Audit. As part of this new structure, you are empowered to use your voice and expertise to have a positive impact on your team, our business, and health technologies that will improve the health, well-being and care for people around world.Business Group Health & Wellness creates meaningful innovations that improve people's lives; our Philips Sonicare and Discus products help provide better health and more beautiful smiles across the globe; our Philips Avent products deliver the promise as the #1 Brand of baby products recommended by moms worldwide.We are looking for:A person who is excited by the unique professional challenges that our Quality Transformation presents, has strong technical competencies, and demonstrates resilience challenging, often demanding situations. We are looking for a perfectionist- a fixer who continuously strives for excellence as a way of life; not just as a job. We’re looking for someone who can inspire others to adopt this mentality of prioritizing quality above all else in a relentless pursuit to improve the quality of life billions for the billions of people Philips brand touches each year.Specific skill requirements for this role include:?A degree in a scientific discipline or equivalent is desirable.?RAC Certification and/or a Masters in Biomedical Regulatory Affairs are also desirable.?Minimum of 5 years’ experience in the pharmaceutical, medical device, biotechnology and/or cosmetic (recent) industries desired.?Candidates should understand the essential framework of regulations and guidelines pertinent to their exposure areas.?Must have a basic grounding in GLP, GCP and GMP.?Must have strong interpersonal and communications skills with strong English language ability.?Must be articulate and able to communicate effectively with employees at all levels of the organization, as well as with key individuals outside the organization. These outside contacts may include Philips personnel from commercial organizations, dealers-distributors, and consultants.Our offerThis role comes with a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Quality is right on the top of Philips leadership agenda and that means you have the unique opportunity to come in and have a recognized voice to drive and witness exciting, transformational changes. You will be empowered to drive high quality, ground breaking innovations with a globally recognized, premium brand behind you. And when you are successful in this role’s mission, you will have an array of diverse career options open to you – across different functional areas, product lines, business groups and/or geographies. That is a commitment Philips Quality Leadership team has made and stands by. 职能类别：医疗器械注册关键字： Regulatory Affairs

公司信息

关于我们荷兰皇家飞利浦(NYSE: PHG, AEX: PHIA)是一家世界领先的健康生活科技公司，致力于通过提供从健康的生活方式，到健康疾病的预防、诊断、治疗和家庭保健一系列的整体解决方案，提升人们的健康和生活品质。飞利浦拥有领先的科学技术以及对临床医学和消费品的独到见解，并将两者结合为人们打造整体健康生活解决方案。公司在影像诊断、图像引导治疗、患者监护、健康信息、健康生活消费品和家庭保健等等方面均居于领先地位。总部设在荷兰，皇家飞利浦拥有约69，000名雇员，在全球超过100个国家和地区设有办事处提供产品销售和服务，2015年健康科技领域的销售额超过168亿欧元。欲了解更多飞利浦新闻请访问http://www.philips.com.cn/a-w/about/news/all-news.html。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。

周边城市招聘：上海浙江安徽广东山东河北重庆北京江苏湖南

企业入驻日期： 2017-11-09

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