Regulatory Intelligence Manager

招聘人数：1-2人 到岗时间：不限 年龄要求：不限 婚况要求：婚姻状况 Regulatory Intelligence Manager







· Support Philips by serving on national standards committees (potentially international) in the development and review of proposed standards to support Philips processes and solutions.



· Partners with the US/EU/CH Regulatory Standards Team to ensure alignment of standards needs across Philips Portfolio.



· Supports and presents Philips positions with Industry Organizations and SDO’s.



· Represents Philips on Technical Committees that are creating consortium or formal (regulatory) standards related to process, product or systems performance.



· Consults with Business Groups on requirements and needs.



Manages assigned S2B (Standards to Business) teams on assigned standards















You are responsible for



· REGULATORY STRATEGY: Responsibilities will focus on China trade and standards organization to optimize utilization, awareness and development of standards. Provide consultancies to China/Global regulatory team while implementing their regulatory strategy.



· INDUSTRY GROUPS: Participate in Local Trade Associations (e.g.; AdvaMed, MDMA, MITA, COCIR, MedTech Europe) representing Philips.



· STANDARDS: Support standards team on analysis, interpretation and dissemination of information as it applies to the US/EU/CH and Global as appropriate requirements.



You are a part of



this Quality & Regulatory (Q&R) role within Philips, your challenge will be drive standards awareness and leadership in support of the businesses needs in standards and regulations within Philips. This involves being a confident communicator, ability to consult with peers on global regulations and standards and support the development of new work initiatives as assigned.



This role reports solid line to the Head of Global Regulations and Standards and partners with the US Regulatory Standards Team on standards strategy within Philips.







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



· Proven ability in understanding US/EU/CH Regulations and the utilization of standards in support of regulatory strategy.



· Ability to communicate effectively internally and externally on Regulatory Strategy and the use of standards.



· Knowledge and awareness of the diverse worldwide medical device regulations, the experience to know how to successfully apply those regulations in an efficient, effective and compliant manner.



· Proven experience in understanding consequences of new and changing regulations and standards to markets and business groups and effectively and pro-actively transferring this knowledge and understanding to all applicable stakeholders to ensure timely compliance with these regulations and guaranteeing continuous market access.



· An ability to successfully lead virtual teams of professionals in order to effectively and efficiently execute key processes particularly in the I2M arena.



· Proven experience in successfully representing organizations in industry associations.



· Experience in continuous improvement initiative and learning techniques.



· Knowledge and expertise in Quality Management Systems and Risk Management Standards – ISO 13485 and ISO 14971.



· Regularly interactices with senior management internally and externally on standards as assigned.



· Supports implementating strategic polices when selecting methods, techniques and evaluation criteria for obtaining results.



· Support senior level standards engineer(s) in regional assignment area.



· Support deployment of standards – training, consulting, guidance











This position requires a Bachelor’s degree, preferably in an engineering or life-scientific discipline, and a minimum of 3 years of experience working in quality and regulatory affairs in medical device arena. Experience in participating in standards work and trade associations. Knowledge of Global Regulations including FDA, ISO 13485. Awareness to activities performed in Research and Development, Sales and Service, Manufacturing, Marketing, IT, Document and Data Management, Purchasing/Procurement, Logistics and Service/Installation.







In return, we offer you



A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this market-based role in a complex environment will open many doors for your long term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.







· A professional but fun workplace, A healthy work-life balance environment;



· An energetic, genuine, inventive, supportive and dynamic team atmosphere;











Why should you join Philips?



Working at Philips is more than a job. It’s a calling to create a healthier society through meaningful work, focused on improving 3 billion lives a year by delivering innovative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways. Learn more by watching this video.







To find out more about what it’s like working for Philips at a personal level, visit the Working at Philips page on our career website, where you can read stories from our employee blog. Once there, you can also learn about our recruitment process, or find answers to some of the frequently asked questions.


年薪30-40万