Job Information
Philips Correction and Removal Manager in Farnborough, United Kingdom
Job title:
As a Corrections and Removal Manager , you will ensure an effective and adequate process for executing field actions / Corrections and Removals in Region Europe Philips organization.
Your role:
Ensures that processes for specifying and executing field actions / corrections and removals are adequate and meet the expectations of all key stakeholders (customers and regulatory agencies).
You will be part of the Corrections and Removal Strategy and Planning team. A cross-functional team between regions quality, regions service, & legal manufacturers (business units), where you will provide feedback and regional input to ensure consistent decision making across Philips Businesses and Markets.
As part of the C&R Strategy meetings, you will need to promptly identify potential reportable and safety related C&R, ensuring timely notification of regulators and affected customers.
You will facilitate the preparation of key field actions documents such as Field Safety Notices and Field Safety Corrective Actions.
Submits FSCA package to the Competent Authorities and or other regulatory agency as required by Country/Market.
Monitors KPI and escalates when needed to ensure timely closure .
Support the resolution and prioritization of field corrections in Europe zones in alignment with C&R priorities across Philips.
The C&R role will focus purely on the C&R & FCO handshakes (Strategy and Planning, including consistent reporting requirements).
You will work together with C&R Specialists in the Western European zones, ensuring that respective processes are timely, effective, and efficient, including tracking statuses of each C&R for Sleep and Respiratory Care.
You're the right fit if you have:
Bachelor of Science in engineering or science degree and a related experience in the medical device.
Direct experience leading post-market/corrections and removals activities.
Background with global medical device regulations, requirements, and standards such as ISO13485, ISO9001, MDD, European Medical Device Regulation (MDR), FDA QSR .
Experience with regulatory audits/inspections.
Experience with corresponding to inquiries associated with corrections and removal regulatory reporting.
Fluent in English (any Scandinavian language – a plus).
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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