Vigilance Manager

Job Title

Vigilance Manager

Job Description

Vigilance Manager - Pittsburgh, PA. USA

The Vigilance Manager 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.

Your role:

• 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.

You're the right fit if:

• You've acquired 5+ years of experience in Medical Device or other regulated industry.
• Your skills include moderate understanding of CAPA, as well as global medical device regulations, requirements, and standards such as 21CFR Parts 803, 806, and 820, ISO13485, ISO1497, and ISO9001.
• You have a 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).
• You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this Office/Remote position.
• You're a self-starter ready to roll up your sleeves and make an immediate impact.

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 improve the lives of others.

• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
• Read more about our employee benefits.

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.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

Company relocation benefits will not be provided for this position. For this position, you must reside in or within commuting distance to Pittsburgh, PA. USA

All United States-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, learn more here.

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