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Senior Manager, Risk Management

Company: Philips
Location: Cambridge
Posted on: January 13, 2022

Job Description:

Job TitleSenior Manager, Risk ManagementJob DescriptionEffective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*. Employees may request a reasonable accommodation.If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may contact 888-367-7223, option 5, for assistance.

  • Montana employees are currently excluded from this requirement at this time.Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.But it's not just what we do, it's who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers' needs. It's what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.The world and our customers' needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That's why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.In this role, you have the opportunity to make life betterLooking at the challenges the world is facing today, Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.Help transform the Philips Product Safety Risk Management (RM), which will help improve the lives of millions of people while advancing the Philips journey as a global leader in Health Technology.This role will have significant visibility and a chance make a real difference to our employees and our customers as we add value through product safety risk management insights. You will implement standard Philips-wide process for identifying, quantifying, mitigating, and monitoring risks associated with Philips products, both medical and non-medical. You will participate as a central team member to the Risk Management Center of Excellence to drive consistency in risk management strategy, development, deployment, and execution throughout all of Philips Businesses. Serve as central team's expert on strategy and execution with the businesses and central teams to ensure consistent implementation of risk management concepts and provide support to resolve regulatory agency requests regarding audits and inquiries.You are responsible forEnsures that the Philips Product Safety Risk Management process complies with all the relevant safety policies, standards, and regulations.
    • Drive implementation of company objectives of Philips Business System 3.0 related to risk management.
    • Being part of the Risk Management central team, continuously evaluate effectiveness of the risk management process to resolve gaps or areas for improvement and solutions to mitigate.
    • Provide expertise to the central team in the development and execution of the overall strategy, relationship, governance, and structure of standardized way of work for risk management.
    • Provide expertise to businesses as they deploy the central process. Understand technical details of implementation of standardized process and provide guidance and direction to businesses. Viewed as an expert in the field for tactical deployment within a business.
    • Accountable for development and maintenance of the central process for Philips ensuring continued compliance and providing support in Center of Excellence governance process related to change management.
    • Partner with businesses, markets, and functions to drive continuous improvement initiatives related to risk management.
    • Partner with allied processes at the Philips central teams level including complaint handling, post market surveillance, corrections and removals, new product development (PDLM) and CAPA to support interconnectivity and improvements.You are part ofAs a result of Philips renewed commitment to Quality, it has recently restructured its organization to ensure you and your department have clear interactions with Philips Business Group and the leadership. 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.Through comprehensive, compliant product safety risk management, you will ensure Philips products set the standard for product safety and effectiveness within their respective markets.To succeed in this role, you'll need a customer-first attitude and the following
      • Strong analytical, conceptual, and creative thinking skills. A problem solving and pragmatic attitude.
      • Master's degree or higher in engineering, science, or clinical field - or equivalent experience.
      • Minimum 5 years' experience in risk management in medical device application both hardware and software.
      • Demonstrated expertise in the application of risk management concepts in allied processes throughout the product lifecycle including new product development, manufacturing, post market surveillance, CAPA and correction and removal.
      • Experience with FDA and/or other regulatory audits/inspections is required.
      • Must have knowledge of regulations related to risk management, and the development of safe hardware and software products including ISO 9001/13485/14971, FDA Regulations 21CFR 820, EU MDR, IEC 60601, IEC 62304, and IEC 62366.
      • Must possess strong customer focus with doing it right the first-time approach and be able to demonstrate high performance behavior of shared accountability.
      • Ability to drive decision-making while effectively communicating detailed information and strategic decisions to project team members of all levels.
      • Experience in both Pre and Post Market risk management preferred.
      • Experience in Research and Development as a member of a product design team preferred
      • Proven experience driving key initiatives or processes in a global, matrixed organization. Experience with leading organizational change preferred.
      • Certification in Quality Engineering or Regulatory preferred.
      • Process excellence or green belt six sigma is preferred.In return, we offer youThe unique combination of a critical and challenging role in a creative and empowering environment. You will be actively encouraged to make improvements and establish best in class ways of working. You will have a direct impact on the success of Philips on a daily basis. As a diversified health and well-being company, Philips focuses on improving people's lives through those timely and meaningful innovationsOur benefits can be found here: 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 innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.Visit our careers website to explore what it's like working at Philips, read stories from our employee blog, find information about our recruitment process and answers to some frequently asked questions.It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.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.Equal Employment and Opportunity Employer/Disabled/Veteran#LI-PH1#LI-Remote

Keywords: Philips, Cambridge , Senior Manager, Risk Management, Executive , Cambridge, Massachusetts

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