Vigilance Reporting Specialist

Philips•New Kensington, PA

2d•$92,000 - $146,000•Onsite

About The Position

Lead complaint operations by resolving complex issues, guiding evaluators, analyzing processes for improvement, and ensuring compliant, data-driven oversight through cross-functional leadership and team development. Your role: Provides guidance on mid-complexity product issues and supports complaint evaluators and investigators by answering questions and ensuring clear communication. Analyzes complaint handling processes, evaluates evaluator and investigator performance, identifies bottlenecks, and recommends process improvements. Resolves complex complaints under broad guidelines, reviews reportability assessments, and escalates issues as needed for further determination. Trains and mentors new complaint operations specialists, develops training materials, and supports ongoing skill development. Leads complaint operations activities, including data analysis, cross-functional collaboration, and oversight of complaint screening, evaluation, and coding accuracy. Monitors team performance, supports management with operational needs, and contributes to process improvements and regulatory compliance efforts.

Requirements

2+ years of experience in medical device or another regulated industry.
Basic understanding of corrective and preventive action.
Knowledge of global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, ISO1497, and ISO9001.
Bachelor’s degree in biomedical engineering, science, healthcare, or in the clinical/medical field.
Must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position.

Responsibilities

Provides guidance on mid-complexity product issues and supports complaint evaluators and investigators by answering questions and ensuring clear communication.
Analyzes complaint handling processes, evaluates evaluator and investigator performance, identifies bottlenecks, and recommends process improvements.
Resolves complex complaints under broad guidelines, reviews reportability assessments, and escalates issues as needed for further determination.
Trains and mentors new complaint operations specialists, develops training materials, and supports ongoing skill development.
Leads complaint operations activities, including data analysis, cross-functional collaboration, and oversight of complaint screening, evaluation, and coding accuracy.
Monitors team performance, supports management with operational needs, and contributes to process improvements and regulatory compliance efforts.