Philips Global Regulations & Standards Director in Cambridge, Massachusetts

Key areas of responsibilities (KARS) for this role include:

  • Actively participates in organizations in Standards Development including holding leadership positions (e.g., AAMI, IEC, ISO, ANSI, NEMA as well as represent Philips/Industry on the National Committee)

  • Actively participates in industry organizations to drive regulatory paradigms (e.g.; DITTA, GMTA, AdvaMed, MITA)

  • 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.

  • Has strong knowledge of company products and services

  • Strong knowledge and expertise in Global Regulations (Particularly US, EU, Japan and China)

  • Advise businessRACAteams on applicable regulations, requirements, andstandards throughout the TPLC

  • Lead and develop RACAprogram(s) and processesto ensure the highestlevel 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

This position requires:

  • Provenleadershipinformulatingandimplementingglobalstrategiestoensure compliance with worldwide regulationstomaximize product market access.

  • Proven experience in Standards Development including horizontal and vertical standards. Key areas of knowledge should include: software, conformity assessment requirements, quality management systems, risk management, alarms, labeling, symbols, sustainability and usability.

  • A comprehensiveunderstandingofthe diverse worldwide medical device regulations, the experienceto know how successfully to apply thoseregulationsinanefficient,effectiveandcompliantmanner Experience for US must include familiarity with ONC as well as FDA and FCC as needed. Experience/engagement with US FDA’s regulatory paradigm activities.

  • Provenexperienceinunderstandingconsequencesof new and changing regulationsto markets andbusinessgroupsandeffectivelyand pro-actively transferringthis knowledge andunderstandingto all applicablestakeholderstoensuretimelycompliance with theseregulationsandguaranteeingcontinuous market access.

  • An ability to successfully lead virtual teams ofRACAprofessionalsexistingof both direct and functional reportsinordertoeffectively and efficiently execute pre-market approvaland post-market surveillance processes.

  • Provenexperiencein successfully representingorganizationsin industry associations.

  • Experience in continuous improvement initiative and learning techniques.

  • The experienceto lead anddevelopstrategies for a multi-site,globalhealthcarebusinesswhilealsobeingabletodesignandexecute specific projectsand lead teams.

  • Knowledge and expertise in SW and Risk Management Standards - ISO 14971, ISO 80001, IEC 62304 and IEC 60601 standards.

This position requires a Master’s degree, preferably in a life-scientific discipline, and a minimum of 12 years of experience working in quality and regulatory affairs within a global medical device industry, of which 7 years were in a senior technical role. Extensive knowledge of Global Regulations including MDD, MedDev’s, FDA QSR’s, ISO 13485. Experience with Research and Development, Sales and Service, Manufacturing, Marketing, IT, Document and Data Management, Purchasing/Procurement, Logistics and Service/Installation. An advanced management degree is strongly preferred.

In this role, you have the opportunity to

Your challenge will be to guide and support Business Groups and Markets in understanding regulations and standards, intelligence gathering and strategic planning along with tactical implementation. This involves being a confident advisor on specifics on how to implement to support TPLC compliance with focus in areas of global submissions and approvals, risk management and quality management related topics to support businesses’ strategic objectives and assurance of safe and effective solutions.

This role reports solid line to the Head of Global Regulations and Standards with the role requiring up to 50% 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 markets.

You are responsible for:

  • Represents Philips externally on technical committees that are creating consortium or formal standards/regulations related to product or solution performance and related areas (horizontal activities like risk management, quality management system, labeling, usability)

  • Consults and advises businesses and/or markets on Regulatory Affairs strategy and requirements for specific new and/or modified standards/regulations to support state of the art solutions

  • Develops work initiatives for standards development and/or regulatory intelligence development to drive continuous improvement

  • Holds leadership positions in Standards and Industry Committees – maintains position of influence with domestic and international organizations to establish or influence future requirements

  • Finds opportunities for future engagement and supports Global Regulations and Standards in overall organization strategy and plans

  • Partners with Business Leadership and Governmental Affairs 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

  • Actively participates in Standards Development including holding leadership positions (e.g., AAMI, IEC, ISO, ANSI, NEMA as well as represent Philips/Industry on the National Committee)

  • Actively participates in industry organizations to drive regulatory paradigms (e.g.; DITTA, GMTA, AdvaMed, MITA)

  • Viewed as an authority 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.

  • Has strong knowledge of company products and services

  • Experienced in Global Regulations (Particularly US, EU, Japan and China)

  • Advise business RACA teams on applicable regulations, requirements, and standards throughout the TPLC

  • Oversees RACA program(s) and processes to ensure the highest level of compliance

  • Participates in corporate development of methods, techniques and evaluation criteria using 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:

As a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear talks 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.

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

  • Validated leadership in formulating and implementing global strategies to ensure compliance with worldwide regulations to maximize product market access.

  • Shown experience in Standards Development including horizontal and vertical standards. Key areas of knowledge should include: software, conformity assessment requirements, quality management systems, risk management, alarms, labeling, symbols, sustainability and usability.

  • A comprehensive 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 for US should include familiarity with ONC as well as FDA and FCC as needed. Experience/engagement with US FDA’s regulatory paradigm activities.

  • Confirmed experience in understanding consequences of new and changing regulations to markets and business groups and effectively and actively transferring this knowledge and understanding to all applicable partners 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 in order to effectively and deftly execute pre-market approval and post-market surveillance processes.

  • Validated experience in successfully representing organizations in industry associations.

  • Experience in continuous improvement initiative and learning techniques.

  • The 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 and expertise in SW and Risk Management Standards - ISO 14971, ISO 80001, IEC 62304 and IEC 60601 standards.

This position requires a Master’s degree, preferably in a life-scientific discipline, and a minimum of 12 years of experience working in quality and regulatory affairs within a global medical device industry, of which 7 years were in a senior technical role. Extensive knowledge of Global Regulations including MDD, MedDev’s, FDA QSR’s, ISO 13485. Experience with Research and Development, Sales and Service, Manufacturing, Marketing, IT, Document and Data Management, Purchasing/Procurement, Logistics and Service/Installation. An advanced management degree is strongly preferred.

In return, we offer you

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global 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 bold health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.

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.

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. 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.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.