Philips Product Hold Post Market Risk Specialist 

Netherlands, North Brabant 

153856032

Product Hold and Post Market Risk Specialist

You are responsible for

• Participating as the PMS representative in the preparation, authoring (when applicable) review and approval of Post Market Risk Assessments and Health Hazard Evaluations.
• Collaborating with key stakeholders required for the execution of Post Market Risk Assessments such as Development, Risk Management and Medical Affairs.
• Supporting consistency of decisions of Health Hazard Evaluation, Product Hold and Field Safety Corrective Actions.
• Managing the Product Hold process for IGT-Systems (Fixed System) for products manufactured in Best (Netherlands).
• Managing the collection of the information required for the Hold determination and the facilitation of Product Hold initiation meetings.
• Being a back up for the creation of documentation required by the Product Hold process (e.g. Hold initiation form, Communication form, UAL and Hold closure forms).
• Supporting the identification and maintenance of appropriate metrics on the efficacy and efficiency of the Post Market risk assessment and Product Hold activities and monitoring and reporting on those metrics.

You are a part of

You will be part of the Post Market Surveillance Team, a young, dynamic and multicultural team.

To succeed in this role, you should have the following skills and experience

• Bachelor’s degree in biomedical engineering, science, healthcare, or medical profession.
• 5 years’ experience in Quality in Medical Device and/or other regulated industry preferably in Risk Management, Design Quality or Correction and Removal/Recalls or product development.
• Focus on detail.
• Good analytical skills and process improvement capabilities
• Teamwork in and outside Quality.
• Strong written and oral communications skills in English and demonstrated ability to effectively communicate technical content to a variety of internal and external audiences (e.g. Authorities, customers).
• High degree of initiative, engagement, self-motivation and flexibility.
• Able to work in a changing environment and be a driver of change.
• Product Knowledge is preferred.

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