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 itu2019s not just what we do, itu2019s who we are. We are 80,000, wonderfully unique individuals, with two things in common. and a relentless determination to deliver on our customersu2019 needs. Itu2019s what inspires us to create meaningful solutions u2013 the kind that make a real difference u2013 when it matters most. The world and our customersu2019 needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. Thatu2019s 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 better Looking at the challenges the world is facing today Philipsu2019 purpose has never been more relevant. So whatever your role, if you share our passion for helping others, youu2019ll be working towards creating a better and fairer future for all. You are responsible for u00A0 Ensures the Policy for Establishing Safety Risk Acceptability for the product is created, approved, and maintained by top management Ensures product safety risk management deliverables are created, maintained, and stored in the Risk Management file during product development Monitors and reports on the productu2019s safety risk management performance in the field and ensures deliverables are updated as needed Ensures the appropriate risk assessments are performed when triggers are met Defend Risk Management and design quality activities during external and internal audits Perform periodic reviews of Risk Management Files and ensure those are performed according to schedule Evaluateu00A0 process and product changes for their impact to the current Risk Management Files. Monitor post product data (e.g. Complaints, Corrective and Preventive Actions (CAPA), Non-conformance Reports (NCRs), Customer Feedback information, etc.) for impact to the Risk Management Files Work with global experts to drive the common practice and best practice across sites for risk management, design regulations compliance and business requirements Coordinates with a cross functional team including Engineering and Medical Affairs in the creation and maintenance of the deliverables listed above To succeed in this role, youu2019ll need a customer-first attitude and the following Bacheloru2019s degree, Engineering or Science discipline preferred or equivalent work experience 3+ years working experience in a regulated industry 3+ years working experience in product development or post-market surveillance, system engineering experience u2013 an advantage Experience in creating risk management deliverables Knowledge of ISO 14971 and product specific regulations and standards u2013 an advantage Clinical knowledge u2013 an advantage How we work at Philips Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart u2013 which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home u2013 for our hybrid roles. Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way. Our hybrid working model is defined in 3 ways: There\'s a certain energy when everyoneu2019s in the same room that can heighten idea generation and creative friction needed for problem-solving. Choosing where, when and how to work can vary according to task and team schedules. Flexibility isnu2019t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis. The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best. Why should you join Philips Working at Philips is more than a job. Itu2019s 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.
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