Post Market Surveillance Manager

2 weken geleden

Best, Noord-Brabant, Nederland Philips Voltijd
About the Role

We are seeking a highly skilled Post Market Surveillance Manager to join our team at Philips. As a key member of our Fiber Optic RealShape (FORS) venture, you will play a pivotal role in disrupting the MedTech industry and making a real difference in the lives of patients.

Key Responsibilities
  • Establish and operationally execute post market activities for FORS technology-based products, ensuring compliance with quality management system processes and regulatory requirements.
  • Lead the adaptation of established ways of working as required by the transition from introducing to maturing a new FORS technology-based product category.
  • Monitor and coordinate input sources to the process, including complaint handling, engineering change orders, regulatory submissions, and field deployments.
  • Manage correction and removals, responses, file documentation, and file completion.
  • Prepare key documents, such as health hazard evaluation documents, correction and removal documents, and product correction and removal files.
  • Continuously track field actions and ensure alignment between risk assessment, management documentation, and documents for correction and removal.
  • Be the local owner of product hold and non-conforming processes.
  • Prepare and lead periodic quality review meetings.
  • Interface between complaint handling unit and the FORS team responsible for programming and executing sustaining activities.
  • Provide 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.
Requirements
  • Rich experience in 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.
About Philips

We are a health technology company built around the belief that every human matters. 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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