Sr. Manager Vigilance Reporting

Job Title

Sr. Manager Vigilance Reporting

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:

As a Senior Manager, you will use your Vigilance Reporting expertise to lead a team of Vigilance Reporting Specialists and implement globally compliant and Philips standardized adverse event reporting policy and processes.

You are responsible for:

• Enforcing standardized and simplified adverse event reporting processes
• Providing functional leadership and subject matter expertise to a team of Vigilance Reporting Specialists who are responsible for world-wide adverse event reporting decision making and report submissions.
• Introducing and implementing adverse event reporting processes and tools required to ensure global regulatory compliance, quality, and patient safety.
• Managing compliance to FDA regulations and other Regulatory Agencies.
• Managing the oversight and review of adverse event reports globally
• Actively participating in inspections and questions relating to the operation of complaint handling operations, processes and procedures in coordination with all other applicable company groups.
• Establishes an effective Management Review process, including routine reporting.

You are a part of:

The Post-Market Surveillance/Vigilance Reporting team is responsible for monitoring, investigating, tracking and reporting on the performance of all Sleep & Respiratory Care products in the field. This activity is undertaken primarily through the management of the Complaint Handling System. The team is responsible for global vigilance reporting of individual events, field actions, communications with regulatory authorities and notified bodies, and creating the data required to drive business critical decisions at the executive level.

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

• Minimum of a Bachelor's Degree in Biomedical Engineering, Science, Healthcare, or Medical profession.
• Minimum of 7+ years' experience in FDA Regulated Medical Device/Technology, with a focus in Adverse Event/Vigilance reporting activities, AND/OR in a licensed/certified capacity as an RN, NP, PA, MD, Respiratory Therapist, Radiation Technologist, Ultrasound/CT Technologist, etc.
• 3+ years' experience in functional/team leadership.
• Strong understanding of CAPA, as well as global medical device/ post market surveillance regulations, requirements, and standards such as- MDD93/42/EEC, 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971 (Risk Management), and ISO 9001
• Previous experience with servicing or supporting Philips's products in the field-desired

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

In return, we offer you:

A path towards your most rewarding career. Philips is growing its marketing capability enterprise wide. Succeeding in this global role in a complex environment will open many doors for your long-term career, in other areas in Philips or otherwise. We also believe that we are at our best as a company when you are at yours as a person. Thus, we offer competitive health benefits, a flexible work schedule and access to local well-being focused activities. Furthermore, Philips University is available to all employees for learning and development opportunities.

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.

#LI-PH1

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 Opportunity Employer/Disabled/Veteran

Philips maintains a drug-free workplace