Complaint Handling and Vigilance Reporting Specialist

Job Responsibilities:
• Works under general supervision and established processes and operational policies with independent judgement, investigates and assists in resolving highly complex complaints by monitoring product analysis findings or service analysis notes and ensures the implementation of solutions to address customer concerns efficiently.
• Leads the implementation of good faith efforts (GFE), diligently reviews, and analyzes supplementary data as required to fortify the investigation process and demonstrates a commitment to thoroughness and accuracy.
• Ensures the application of internal follow-up measures to procure further essential information necessary for reinforcing the investigation process, ensuring thoroughness and accuracy in analysis and decision-making.
• Establishes standards for appropriate coding to records as input for the complaints process, coordinates requests for new coding, when necessary, ensures all systems and tools are updated, and reviews and updates complaints as new codes become available.
• Leads the end-to-end investigation of complaints, including condensing pertinent information, analyzing findings, and presenting a concise overview of the inquiry process, including key issues identified, evidence gathered, and resolutions proposed or implemented.
• Reviews customer response letters (CRL) or internal responses upon concluding the investigation, utilizes effective communication and problem-solving skills, and escalates complex matters to appropriate channels for further assistance and resolution.
• Utilizes analytical skills to resolve medium complexity requests by exercising judgment within established procedures, analyzing complaint data, gathering additional information to assess potential product enhancements, defects, and safety issues.
• Handles moderate to high complexity investigations into post-market complaints and adverse events, ensures thorough and timely resolution by analyzing complaint data and documentation to identify trends, root causes, and potential product issues.
• Develops detailed investigation plans with clear objectives, methodologies, and timelines, conducts root cause analyses to identify underlying issues and documents findings, corrective actions, and preventive measures in comprehensive reports.
• Supports the training and qualification of new PMS complaint operations investigators, provides guidance, resources, and hands-on instruction to facilitate their understanding of complaint handling processes, regulatory requirements, and best practices.

• Prepare and submit regulatory report to competent authorities such as NMPA, FDA and others) as per defined regulatory timelines.
Minimum required Education:
Bachelor's Degree/ Vocational Education in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management or equivalent.
Minimum required Experience:
No prior experience required with Bachelor's OR minimum 4 years of experience in Medical Device, Quality Assurance, Quality Control, Clinical Research or equivalent with Vocational Education.
Preferred Skills:
• Post-Market Surveillance Mechanisms
• Quality Management Systems (QMS)
• Quality Specifications
• Data Analysis & Interpretation
• Regulatory Requirements
• Technical Documentation
• Root Cause Analysis (RCA)
• CAPA Methodologies
• Complaint Management
• Recordkeeping
• Vigilance Reporting
• Training Delivery
• Business Acumen

How we work together
We believe that we are better together than apart. For our office-based teams, this means working in-person at least 3 days per week.
Onsite roles require full-time presence in the company’s facilities.
Field roles are most effectively done outside of the company’s main facilities, generally at the customers’ or suppliers’ locations.
Indicate if this role is an office/field/onsite role.
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 the lives of others.
• Learn more about our business.
• Discover our rich and exciting history.
• Learn more about our purpose.
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 culture of impact with care here.