Corrections and Removals Specialist

Job Title
Corrections and Removals Specialist

Job Description

If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive additional information about the compensation and benefits for this role, which we will provide upon request. You may c ontact 888-367-7223, option 5, for assistance.

Philips is a global leader in health technology, committed to improving billions of lives worldwide and striving to make the world healthier and more sustainable through innovation. Driven by the vision of a better tomorrow.

But it's not just what we do, it's who we are. We are 80,000, wonderfully unique individuals, with two things in common: An unwavering sense of purpose and a relentless determination to deliver on our customers' needs. It's what inspires us to create meaningful solutions - the kind that make a real difference - when it matters most.

The world and our customers' needs are changing faster than ever before and while we are proud of what we do already, we know we can do more. That's why we need you, to help us tackle increasingly complex challenges posed by ever evolving health and well-being needs.

In this role, you have the opportunity to make life better

Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and fairer future for all.

Monitors and coordinates recall field action programs for medical and consumer products. Prepares required documentation of field actions. C&R strategy, C&R action plan, C&R communications to customers and regulatory bodies, launches recall, monitors recalls progress, determines effectiveness and closes corrections.

You are responsible for

• Ensues that processes for specifying and executing recalls Corrections & Removals are adequate to ensure the expectations of all key stakeholders ae met
• Monitors and coordinates the different sub system feeders to this process such as Issue Impact Assessment, HHE and Benefit risk analysis, Engineering changes orders, regulatory submissions, field deployment and Correction and removal board meetings
• Prepares key documents such as HHE, CAPA summaries, Regulatory notifications, U.S. and OUS, Customer communications, assists with FAQs and holding statements, Corrections & Removals strategy and planning documents,
• Initiates Corrections & Removals File, monitors and keep file up to date
• Participant, an key point of contact as SME for in internal and external audits
• Establishes and monitors reports to provide applicable regulatory status updates
• Provides relevant feedback and insights from customers/filed to development engineering teams to ensure learning from previous projects and captured, synthesized and made available for next project teams
• Continuously tracks Corrections & Removals and provide ongoing information to regulatory bodies
• Establishes and monitors reports on metrics on the efficacy of the Corrections & Removals Process, participates in daily management
• Submits MDR/MIR FSN communication to competent authorities and other regulatory bodies as required
• Monitors KPI and escalate when needed to ensure timely closure

You are part of

The Connected Care (CC) Business is a global health technology leader in Hospital Patient Monitoring, Emergency Care, Sleep and Respiratory Care, EMR & Care Management, Ambulatory Patient Monitoring and Clinical Data Services. By advancing connected care, we seamlessly connect patients and caregivers across care settings, delivering clinical, operational and therapeutic solutions that improve health outcomes, patient and staff experience and lower costs.

To succeed in this role, you'll need a customer-first attitude and the following

• Bachelors degree ( in a science or engineering degree is a plus)
• Project management with post market experience is a plus
• Strong analytical skills, conceptual and creative thinking skills
• Experience with FDA, and EU MDR reporting requirements
• Previous direct involvement in corrections and removals
• Must take learning into their own hands, self-starter and self-driver
• Knowledge of regulations relative to corrections and removals, complaint handling, MDR and AE reporting, risk management such as ISO9001/13485/14791, FDA Regulations (21CFR 803,806, 820) MDD 93/42/eec, 98/79/EC and EU MDR
• Experience with FDA and other regulatory audits/inspections
• Must have a strong customer focus with doing it right the first-time approach and be able to demonstrate high performance behavior of shared accountability
• Ability to communicate very detailed information and decisions to project management team
• Process excellence or green belt preferred
• Proficient with excel, power point, viso, project planner and other visualization, data analysis project management tools

In return, we offer you

The ability to collaborate with, learn and grow from colleagues in a highly complex, global organization where you can use your strengths to help drive strategic business initiatives for Philips. Additionally, we provide you a dynamic working environment in an innovative business, paired with a competitive salary, excellent benefits, and a supportive atmosphere where you can sharpen your talents with new challenges and career opportunities.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

How we work at Philips

There are three core ways that define our ways of working - embracing flexibility, being at our best, and impactful collaboration . We believe this enables us to deliver an outstanding experience to our customers and create the best place to work for people who share our passion.

We know just how important direct interactions are and work is more engaging when we are more frequently face-to-face, and that we experience better collaboration which drives innovation. While we have many different types of roles across Philips most require a combination of in-person collaboration with colleagues and partners, usually at a Philips location, and individual focus time, which can be done remotely.

Why should you join Philips?

Working at Philips is more than a job. It's a calling to create a healthier society through meaningful work, focused on innovative, customer-first health technology solutions. Help us improve the health and well-being of billions of people, every year. Ultimately creating a career that no one could have planned for. Even you.

Visit our careers website to explore what it's like working at Philips , read stories from our employee blog , find information about our recruitment process and answers to some frequently asked questions .

It is the policy of Philips to provide equal employment and advancement opportunities to all colleagues and applicants for employment without regard to race, color, ethnicity, religion, gender, pregnancy/childbirth, age, national origin, sexual orientation, gender identity or expression, disability or perceived disability, genetic information, citizenship, veteran or military status or a person's relationship or association with a protected veteran, including spouses and other family members, marital or domestic partner status, or any other category protected by federal, state and/or local laws.

As an equal opportunity employer, Philips is committed to a diverse workforce. In order to ensure reasonable accommodation 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.

Equal Employment and Opportunity Employer/Disabled/Veteran

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