Post Market Project Manager
In this role you will ensure that processes for specifying and executing field actions are adequate to ensure the expectations of all key stakeholders are met. You will monitors and coordinate the different sub-system feeders to this process such as complaint handling, engineering change orders, kit suppliers, regulatory submission and field deployment. Finally, you will prepare key documents such as Health Hazard Evaluation documents, Correction and Removal documents, product recall files and various internal reports. Ensures alignment between risk assessment and management.
You are responsible for
- Ensuring that processes for specifying and executing field actions of medium complexity are adequate to ensure the expectations of all key stakeholders are met
- Leading cross functional team to release on time, high quality and compliant field actions of high complexity
- Managing recall responses, recall file documentation and recall file completion
- Preparing key documents such as Health Hazard Evaluation documents, Correction and Removal documents, product recall files and various internal reports
- Continuously tracking field actions and provide ongoing information to FCO team as required
- Ensuring alignment between risk assessment and management documentations and documentation for field actions
- Managing recall responses, recall file documentation, recall file completion
- Providing relevant feedback and insights from customers/filed to development/engineering teams to ensure learnings from previous projects are captured, synthesized and made available for next project teams
- Continuously tracking field actions and providing ongoing information to Regulatory Operations as required
To succeed in this role, you should have the following skills and experience
- Bachelor’s degree
- 3+ years experience in a medical device and/or other regulated industry (Pharma, IVD).
- 3+ years of working knowledge of appropriate global medical device regulations, requirements, and standards such as ISO 13485 and ISO9001, and FDA QSR.
Why should you join Philips?
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