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
As a complaint investigator, you will support MDR/adverse event reporting, triage complaint records, manage high-risk complaints to CA.
You are responsible for
Leads team of investigators responsible to evaluate, investigate, and resolve complaints.
Completes initial assessment of reportability and escalate to the manager when necessary to determine action.
Analyzes complaint data, gathers additional data as needed, and partners cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations, and resolve complaints.
Ensure accurate documentation of evaluation and investigation results with the assigned complaint records.
Completes initial assessment of reportability and escalates to manager to determine action, when necessary.
Ensures timely medical device reporting by assessing complaints against reporting requirements and facilitating any required further investigation.
Write and submit medical device reports (MDRs) and / or regulatory reporting.
Provides consultation to investigator during initial check/ reportability determination
Provides review of complaint to ensure all information needed for Reporting/MDRs is present; determine if further investigation is needed and track investigation to conclusion
Analyzes complaint data, gathers additional data as needed, and partners cross functionally to share feedback to the development and manufacturing teams on potential product improvements, product defects, and safety evaluations, and resolves complaints.
Assist in trending of complaints and collaborate with the appropriate groups to ensure that the data got pushed to the appropriate departments for actions.
Support reviews and audits assigned.
Support Product Hold review, CAPA review; PMRA;
Other post market surveillance tasks.
You are a part of
The Emergency Care and Resuscitation Solutions (ECR) Post Market Surveillance Team is headquartered out of Andover, MA. We welcome you to join Philips HealthTech as a Complaints Specialist supporting ECR. The Quality and Regulatory team enables meaningful innovation for our customers by partnering with and guiding the business to achieve world-class quality and regulatory compliance in a rapidly changing environment, while creating a great workplace for our people to realize their career aspirations.
To succeed in this role, you’ll need a customer-first attitude and the following
Bachelor’s degree required. Technical degree in scientific or healthcare-related;
3 years’ experience working in a post market role preferred.
Experience with Complaint Handling Software, Databases, and Microsoft Office.
Excellent communication skills (verbal, written, and presentation)
Medical device and or other regulated industry (Pharma, IVD) preferred
Basic knowledge of ISO13485
Local post market surveillance regulation (21CFR, MDD, EU-MDR and other applicable market regulation) and ISO14971;
Previous experience in medical device and or applicable product;
Product knowledge is preferred.
Ability to effectively manage time.
Ability to handle multiple task assignments.
In return, we offer you
At Philips, we strive to make the world healthier and more sustainable through innovation, and our goal is to improve the lives of 3 billion people a year by 2025. This position offers the opportunity to influence regulatory compliance worldwide and directly improve the customer and patient experience. We offer competitive health benefits, a flexible work schedule and access to local well-being focused activities.
How we work at Philips
Our newly-adopted hybrid work concept fuses flexibility with collaboration to deliver great outcomes for our people and our customers. We are embracing an approach wherein we spend more time together than apart – which for full-time employees translates to an average of at least 3 days working from the office and up to 2 days from home – for our hybrid roles.
Hybrid work flexibility means people can meet the changing demands of work and home in the most balanced, productive, and healthy way.
Our hybrid working model is defined in 3 ways:
We believe in the importance of impactful collaboration: There's a certain energy when everyone’s in the same room that can heighten idea generation and creative friction needed for problem-solving.
We embrace flexibility: Choosing where, when and how to work can vary according to task and team schedules. Flexibility isn’t office or online, it means choosing the space that works best for you, your teams and our customers on a case-by-case basis.
We want to be at our best: The way we work and our workspaces are designed to support our well-being, offer career advancement opportunities, and enable us to be at our best.
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.
Over 125 years ago, Frederik and Gerard Philips started a small light bulb company in Eindhoven. Little did they realize that it would become a global force of innovation, committed to improving billions of lives worldwide. But it did. Today, Philips is a world leading health technology company with a vision to make life better for people worldwide through meaningful innovation. Making good on this promise depends on our passionate, inspirational, collaborative and diverse team. We have over 80,000+ brilliant people around the world but are always looking for more. Like-minded, motivated, focused minds to join us in creating a healthier, more connected society while tranforming themselves personally and professionally. Working at Philips is more than a job. It's an experience filled with unexcepted moments that will transform you in lasting and positive ways. Help us improve the world for the better while building a career that no one could have planned for. Even you.