Correction and Removal Specialist
Correction and Removal Specialist
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Job Description
Job Title
Correction and Removal SpecialistJob Description
Join the Europe Region Correction and Removal (C&R) team and play a key role in safeguarding patient safety and product this cross-functional environment youll collaborate with diverse teams to drive timely and compliant actions on distributed productsensuring satisfaction across customers regulatory authorities and internal stakeholders.
Your role:
Contributing to support the International Region Central Team in the development of the C&R Strategy and ensure alignment with local key stakeholders.
Drives timely execution of C&R strategies as applicable for the local organization
Supporting timely reporting and closure of FSCA to Competent Authorities within the Region/Zone
Supporting timely closure of the Competent Authority Inquiries related to C&R in collaboration with Business.
Supporting timely completion of Customer Notification and Due Diligence within the Region
Supporting C&R alignment and continuous improvement in the Region
Reviewing C&R communication regarding when necessary
Ensuring escalations to relevant partners for C&R
Providing relevant feedback and insight from competent authorities customers and field to Business to ensure continuous improvements.
Supporting of the Monitoring of C&R related KPIs and escalate timely when needed.
Supporting the resolution of FCO prioritization locally in alignment with C&R priorities.
Managing C&R files and documentation
Support the preparation of responses to Regulatory agencies inquiries and provide follow up.
Support the efficacy and efficiency of C&R processes and monitor and report on C&R metrics.
Engage with Philips C&R teams to support continuous improvement effort in the C&R process.
How we work together
We believe that we are better together than apart. For our office-based teams this means working in-person at least 3 days per week. Onsite roles require full-time presence in the companys facilities. Field roles are most effectively done outside of the companys main facilities generally at the customers or suppliers locations.
This role is an office role.
Youre right for this role if:
A Bachelors or Masters degree in a technical field ideally within Healthcare Engineering or Life Sciences
Minimum of 2 years experience in Correction & Removals Field Actions & Returns or Post-Market Surveillance
Solid understanding of medical device regulations including 21 CFR Parts 803 806 and 820; EU MDR (Regulation (EU) 2017/745); ISO 13485; and ISO 14971
Project management expertise or a strong interest in this field is required
Excellent analytical capabilities a structured approach to work and the ability to prioritize tasks in a fast-paced environment
Clear and confident communication skills with the ability to collaborate across functions and levels
If youre 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 .
About Philips
We are a health technology company. We built our entire company around the belief that every human matters and we wont 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.
Learn more about our business here
Discover our rich and exciting history here
Learn more about our purpose here
About Philips UKI
In the UK we are recognised as a Disability Confident employer and are proud to be part of the Armed Forces Covenant & Mental Health at Work Commitment. We welcome all applicants including those from minority backgrounds LGBTQIA and individuals living with a disability.
Because we are at our best when you are you can safely share any reasonable tools or adjustments needed during our recruitment process and beyond.
We are committed to fostering a flexible work environment that is conducive to personal and professional growth and encourage open discussions around flexible working options to ensure we tailor a working arrangement suitable to individual needs while aligning with business goals. If you have specific flexible working requirements please feel free to discuss these during these with your TA Consultant.
For more information read our Inclusion and Diversity Policy and to know more about your Human Rights we encourage you to view this report.
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Required Experience:
Unclear Seniority
Employment Type
Full-Time
