Posted on Oct 12th 2019

Regulations & Standards Senior Manager

中国,北京,北京

Full time

336773

保存职位

Posted on Oct 12th 2019

中国,北京,北京

Full time

454153

保存职位

Job Title

Regulations & Standards Senior Manager

Job Description

In this role, you have the opportunity to

  • Represents Philips externally on technical committees (national committees and working groups) that are creating consortium or formal regulations and/or standard related to product or solution performance and related areas (horizontal activities like risk management, quality management system, labeling, usability).  Must have a wide range of experience, use of professional concepts and ability to address specialized areas both broadly and deeply.  Needs to be viewed across Philips and externally as an expert in Chinese regulatory and standards intelligence. 
  • Consults and advises businesses and/or market on Regulatory Affairs strategy and requirements for specific new and/or modified standards/regulations to support state of the art solutions
  • Develops regulatory strategy to support interactions with regulators leveraging global network and benchmarking.  
  • Develops work initiatives for regulatory intelligence development to drive continuous improvement within Business/Market/Functions within Philips.
  • Holds key positions in Industry Committees – maintains position of influence with domestic and/or international organizations to establish or influence future requirements
  • Provides leadership direction on understanding, interpret and implement standards and regulations 
  • Identifies opportunities for future engagement and supports Head of Global Regulations and Standards in overall organization strategy and plans
  • Partners with Business and Markets Leadership to ensures necessary relations with respective regulators in the applicable markets are built and maintained directly and/or with the markets Q&R leadership and/or Global Regulations & Standards Team

You are responsible for

  • Work with colleagues in GRS on Regulations Input and Standards Development activities and how it impacts regulatory activities including participating in external committees as well as internal Standards Groups(S2B)
  • Actively participates in regional industry organizations to drive regulatory paradigms including working with DITTA and GMTA as necessary.  
  • Viewed as an expert by the company and in the field.  Having a broad expertise or unique knowledge, uses skills to contribute to development of Philips objectives and principles and to achieve goals in creative and effective ways.   Able to negotiate across broad stakeholders (internal & external). 
  • Has strong knowledge of company products and services to support consultations as well as input into future regulatory strategic planning.  
  • Strong working knowledge in Global Regulations (Particularly Americas, EU, Japan and China)
  • Advise business RA teams on applicable regulations, requirements, and standards throughout the TPLC including supporting the development and deployment of educational programs across stakeholders. 
  • Lead and develop RA program(s) and processes to ensure the highest level of compliance
  • Participates in corporate development of methods, techniques and evaluation criteria leveraging standards and regulations expertise
  • Ability to develop and deploy training on standards development and standards & regulations assessment, deployment and implementation
  • Ability to collect and analyze Philips inputs for consensus decisions 

You are a part of

This role reports solid line to the Head of Global Regulations and Standards with the role requiring up to 40% travel both domestically and internationally.  Position will have no direct reports but will be responsible for mentoring and guiding colleagues within team as well as across the businesses and market.

As a result of Philips renewed commitment to Regulatory and 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 the Centers of Excellence (COEs). These 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.  

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

  • Bachelor’s degree, preferably in a life-scientific discipline
  • Minimum of 6 years of experience working in quality and regulatory affairs within a global medical device industry.
  • Knowledge of Global Regulations including EU MDR, FDA QSR’s, ISO 13485.
  • Experience with working with key stakeholders - Research and Development, Sales and Service, Manufacturing, Marketing, IT, Document and Data Management, Purchasing/Procurement, Logistics and Service/Installation.
  • Proven leadership in formulating and implementing global strategies to ensure compliance with worldwide regulations to maximize product market access.
  • Proven experience in Standards utilization/implementation including horizontal and vertical standards.  Key areas of knowledge include: software, conformity assessment requirements, quality management systems, risk management, alarms, labeling, symbols, sustainability, usability. 
  • An understanding of the diverse worldwide medical device regulations, the experience to know how successfully to apply those regulations in an efficient, effective, and compliant manner, Experience with US FDA’s and EU MDR regulatory paradigm activities. 
  • Proven experience in understanding consequences of new and changing regulations 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 RACA professionals existing of both direct and functional reports. Execute pre-market approval and post-market surveillance processes effectively and efficiently.
  • Experience in successfully representing organizations in industry associations.
  • Experience in continuous improvement initiative and learning techniques. 
  • Experience to lead and develop strategies for a multi-site, global healthcare business while also being able to design and execute specific projects and lead teams.
  • Knowledge in Horizontal Standards - ISO 14971, ISO 13485 and IEC 60601 standards. 

In return, we offer you

a competitive compensation offering and a generous holiday / vacation offering, but that’s not all. Regulatory/Standard/Quality are 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. 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 Leadership team has made and stands by.
 

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, and protected veteran or marital status.

Why should you join Philips?

Working at Philips is more than a job. It’s a calling to build a healthier society through meaningful work, passionate about improving 2.5 billion lives a year by delivering creative solutions across the health continuum. Our people experience a variety of unexpected moments when their lives and careers come together in meaningful ways.

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 (https://www.careers.philips.com/global/en) 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.

Philips is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex (including pregnancy), sexual orientation, gender identity, national origin, genetic information, creed, citizenship, disability, protected veteran or marital status.

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Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally. Working at Philips is more than a job. It's an experience filled with unexcepted moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.

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