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Vigilance Reporting Specialist

4 months ago

Pittsburgh, Pennsylvania, United States Philips Full time
Job TitleVigilance Reporting SpecialistJob Description

Ensures timely global medical device reporting by assessing complaints against reporting requirements and facilitating any required further investigation. Writes and submits medical device reports (MDRs) and /or regulatory reporting.

In this role you will be 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 complaints 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

You're the right fit if:

  • 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+ 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.
  • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

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.

Additional Information

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 will reside in or within commuting distance to Nashville, TN., or Cambridge, MA., or Plymouth, MN., or Orlando, FL., Pittsburgh, PA., USA

This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

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