Correction and Removal Specialist

Job Title

Correction and Removal Specialist

Job Description

Being part of the Europe Region Correction and Removal (C&R) process will allow you working with cross functional teams to ensure that appropriate actions are taken on distributed products, ensuring patient safety, product quality and customer and competent authorities satisfaction.

You are responsible for:

• Contributing to support to IR CoE and Business in the development of the C&R Strategy and ensure alignment with local key stakeholders.
• Drives timely execution of Corrections & Removals (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.

You are part of

Region Europe Correction and Removal team and will be reporting to the Head of Quality Europe C&R.

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

• Master/Bachelor in a Technical Discipline preferably in Healthcare, Engineering or Science.
• 2+ years of Correction and Removal experience.
• Project Management skills.
• In-depth knowledge and understanding of Correction and Removal related regulation (e.g. 21 CFR Parts 803, 806, and 820, EU MDR – Regulation (EU) 2017/745, ISO 13485, ISO 14971,
• Good analytical skills and process improvement capabilities.
• 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).
• Ability to successfully balance and prioritize multiple ongoing projects/tasks.
• Strong attention to detail and accuracy.
• High reliability and quality focus.
• High degree of initiative, engagement, self-motivation and flexibility.
• Able to work in a changing environment and be a full supported of change.

About Philips

We are a health technology company. We built our entire company around the belief that every human matters, and 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.

• Learn more about our business.

• Discover our rich and exciting history.

• Learn more about our purpose.

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.

About Us

At Philips, we believe that every human matters. As a global health-tech leader, we focus on improving people’s health and wellbeing through meaningful innovation. The people who work here share our passion and are motivated to bring this purpose to life.

For more than 130 years, we have been creating technologies and innovations that improve people's lives and support healthcare practitioners. Headquartered in the Netherlands and operating in more than 100 countries globally, we focus our advanced technology and deep clinical and consumer insights on Precision Diagnosis, Image Guided Therapy, Enterprise Informatics, Monitoring/ Connected Care, Sleep & Respiratory Care and Personal Health.

Together, we deliver better care for more people because we believe that every human matters. That's why we're taking steps to create an environment where we acknowledge and embrace our differences and uniqueness and listen to and value each other's views. When people feel cared for and listened to, they bring their best qualities to work, leading to better collaboration, communication, innovation and success.

It is the policy of Philips to provide equal employment and advancement opportunities to all qualified employees and applicants for employment without regard to race, color, religion, sex, pregnancy/childbirth or related medical conditions, age, ethnic or national origin, sexual orientation, gender identity or expression, physical or mental disability, genetic information, citizenship status, veteran or military status, marital or domestic partner status or any other characteristic protected by law. As an equal opportunity employer, Philips is committed to fostering a culture where all are treated with respect and professionalism.

To ensure reasonable accommodations for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veterans' Readjustment Act of 1974 and Title I of the Americans with Disabilities Act of 1990, applicants that require accommodation in the job application process may contact 888-367-7223, option 5, for assistance.

Philips is an Equal Employment and Opportunity Employer including Disability/Vets and maintains a drug-free workplace.

Know Your Rights