Vigilance Reporting Specialist

Job Title

Vigilance Reporting Specialist

Job Description

Effective Tuesday, January 4, 2022, all U.S.-based employees are required to be fully vaccinated against COVID as a condition of employment at Philips*. Employees may request a reasonable accommodation. *Montana employees are currently excluded from this requirement at this time.

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 contact 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.

You are responsible for

• Works with a variety of diverse persons within the company such as Complaint Investigators, PMS Clinical Experts, CH Market Experts, Engineers, Scientists, Field Service & Application Engineers and Manufacturing personnel to facilitate reportable device events in accordance with written procedures and global reporting requirements.
• Utilizes global decision trees and country specific exemptions to determine worldwide complaint reporting requirements and serious public health threat applicability in accordance with written procedures and global reporting requirements
• Collaborates with Level 3 complaint investigator to determine the need for Clinical Assessment and Clinical Harm Review.
• 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.
• Writes MDRs/MIR reports and submits to the necessary authorities
• Monitors and improves tracking/control systems for medical device reporting
• Investigates and prepares responses to address Competent Authority inquiries and provide follow-up
• May perform complaint investigation activities upon request
• May perform other duties as assigned

You are part of

Consists of members of the Sleep & Respiratory Care Post Market Surveillance team and directly reports to the Vigilance Manager.

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

Required:

• Excellent reading and writing skills.

Preferred:

• Bachelor's Degree or higher in biomedical engineering, science, healthcare, or medical profession (Associates degree may be considered for individuals with at least 5 years hands-on patient care experience or experience with servicing or supporting the product(s) or similar product(s) in the field).
• Previous experience working as a biomedical engineer/risk manager OR in a licensed/certified capacity in a health care role such as an RN, NP, PA, MD, (Respiratory Therapist, Radiation Technologist, Ultrasound Technologist, CT technologist, EMT, etc. may be considered if applicable to product being supported) OR previous experience with servicing or supporting the product or similar products in the field OR previous experience working as a Vigilance Reporting Specialist supporting the product(s) or a similar product(s).
• 1-3 years' experience Medical Device and or other regulated industry.
• Basic understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO1497, and ISO9001.
• Global post market surveillance regulation (21CFR, MDD93/42/EEC and other applicable global regulations), ISO14971 Risk Management.

In return, we offer you

The unique opportunity to jump start your career by working for a global leader in the medical device industry from your home office!

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

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.

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.

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Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.