Philips Post Market Surveillance Manager 

Germany, Hesse 

266929299

Post Market Surveillance Manager
Job Description

You establish and 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, FORS operates under its own QMS. 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:

• Ensuring that processes for specifying and executing corrections and removals are adequate to meet all requirements
• Monitoring and coordinating the different input sources to this process such as complaint handling, engineering change orders, regulatory submissions and field deployments
• Managing correction and removals: responses, file documentation and file completion
• Preparing key documents such as health hazard evaluation documents, correction and removal documents, product correction and removal files
• Continuously tracking field actions
• Ensuring alignment between risk assessment, management documentation and documents for correction and removal
• Being local owner of product hold and non-conforming processes
• Preparing and the periodic quality review meetings
• Being the interface between complaint handling unit and the FORS team responsible for programming and executing sustaining activities
• 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:

• 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)
• Knowledge in regulatory affairs (e.g. EU MDR, QSR)
• Excellent analytical and conceptual skills
• Outstanding communication and interpersonal skills to interact across functions and organizations
• Ability to adapt to changing needs
• Structured way of working
• Project management skills
• Hands-on mentality
• Team Player

We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.
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