Post Market Surveillance Manager
Hold a pivotal position in the Fiber Optic RealShape (FORS) venture to disrupt MedTech and make a real difference.
LumiGuide powered by FORS technology is new to the world and a crucial step in our Image Guided Therapy (IGT) purpose of treating patients better by innovating minimally invasive procedures. More about LumiGuide powered by FORS: www.Philips.com/FORS-technology
In this customer-centric, fast-learning and agile venture environment we value drive, creativity and solution oriented end-to-end business thinking, and we are looking to hire a Post Market Surveillance Manager to fulfil a key role for IGT FORS. In active engagement with key team members you will establish and operationally execute post market activities for the maturing category of FORS technology-based products. You will do so based on a deep understanding of the quality management system processes as well as normative and regulatory requirements.
To date, IGT FORS operates under its own QMS. IGT FORS is on a path from introducing to maturing a new FORS technology-based product category. You are expected to lead the adaptation of established ways of working as required by that transition.
Your role:
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Ensuring that processes for specifying and executing corrections and removals are adequate to meet all requirements
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Monitoring and coordinating the different input sources to this process such as complaint handling, engineering change orders, regulatory submissions and field deployments
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Managing correction and removals: responses, file documentation and file completion
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Preparing key documents such as health hazard evaluation documents, correction and removal documents, product correction and removal files
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Continuously tracking field actions
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Ensuring alignment between risk assessment, management documentation and documents for correction and removal
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Being local owner of product hold and non-conforming processes
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Preparing and the periodic quality review meetings
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Being the interface between complaint handling unit and the FORS team responsible for programming and executing sustaining activities
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Providing relevant feedback and insights from customers, development and engineering teams to ensure learnings from previous projects are captured, synthesized and made available for future project teams
You're the right fit if:
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Rich experience in the field of complaint handling and vigilance activities in a medical device environment, e.g. experience in medical QMS (e.g. ISO 13485)
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Knowledge in regulatory affairs (e.g. EU MDR, QSR)
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Excellent analytical and conceptual skills
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Outstanding communication and interpersonal skills to interact across functions and organizations
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Ability to adapt to changing needs
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Structured way of working
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Project management skills
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Hands-on mentality
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Team Player
About Philips
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If you’re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.
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