Post Market and Complaint Analyst

Meridian Bioscience International Limited; North Billerica (MA); On-site; USD 90,000 - 115,000; Full time

Job summary

Meridian Bioscience International Limited in the United States is seeking a Post Market and Complaint Analyst to manage complaint handling, product quality investigations, and post-market surveillance for diagnostic products. This role ensures regulatory requirements are met and supports CAPAs to maintain product safety and quality.

You will collaborate with Quality, Regulatory Affairs, Manufacturing, and Technical Support to gather data, trend issues, and prepare reports for MDR and other

Qualifications

• Bachelor’s degree in biology, chemistry, microbiology, engineering, or a related discipline.
• 2–5 years of experience in complaint handling, post-market surveillance, quality assurance, regulatory affairs, or related field.
• Experience in regulated industries such as medical devices preferred.
• Knowledge of FDA QSRs, ISO 13485, EU MDR, and post-market surveillance requirements.
• Understanding of complaint handling, CAPA, risk management, and adverse event reporting.
• Familiarity with root cause analysis methodologies (5-Why, Fishbone, FMEA).
• Proficiency with Microsoft Office and eQMS.

Responsibilities

• Receive, review, document, and process customer complaints per procedures.
• Investigate complaints to identify causes and potential risks.
• Review device history records and quality documentation to support investigations.
• Prepare investigation summaries and closure within timelines.
• Support post-market surveillance activities and trend analysis.
• Assist with regulatory reporting including MDR and adverse event reporting.
• Collaborate with cross-functional teams to implement CAPAs.
• Maintain accurate complaint records in the eQMS.
• Participate in audits and inspections related to complaint handling.

Skills

Strong analytical and investigative

Excellent written and verbal comms

Attention to detail

Cross-functional collaboration

Education

Bachelor’s Degree in Biology, Chemistry, Microbiology, Engineering or related discipline

Tools

Microsoft Office

eQMS

Job description

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision.Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

The Post Market and Complaint Analyst is responsible for managing complaint handling, product quality investigations, post-market surveillance activities, and regulatory reporting support for medical device and diagnostic products. This role ensures customer complaints are evaluated, investigated, documented, and trended in accordance with applicable regulatory requirements, company procedures, and quality standards. The incumbent serves as a key contributor in identifying product quality issues, supporting risk assessments, monitoring product performance in the field, and facilitating corrective and preventive actions to maintain product safety, quality, and regulatory compliance.

Key Duties

Complaint Handling and Investigation

• Receive, review, document, and process customer complaints in accordance with established procedures and regulatory requirements.
• Escalate significant product quality, safety, or compliance concerns to management for review and decision-making
• Conduct complaint investigations to determine the nature, extent, and potential causes of reported product issues.
• Gather and evaluate complaint-related information from customers, technical support personnel, manufacturing records, service reports, and returned product analyses.
• Review Device History Records (DHRs), production records, and quality documentation to support investigations.
• Document investigation results and prepare complaint investigation summaries and conclusions.
• Ensure complaints are processed and closed within established timelines and quality system requirements.

Post-Market Surveillance

• Support post-market surveillance activities for commercialized products.
• Monitor customer feedback, complaint data, adverse events, service records, and product performance information.
• Perform complaint trending and statistical analysis to identify recurring issues, emerging risks, and opportunities for improvement.
• Prepare periodic post-market surveillance reports, metrics, and management review summaries.
• Assist in assessing field performance and product reliability trends.

Regulatory Reporting and Compliance

• Evaluate complaints and adverse events for potential regulatory reporting requirements.
• Support Medical Device Reporting (MDR), Vigilance Reporting, Adverse Event Reporting, and other post-market regulatory obligations.
• Maintain complaint files and supporting records in compliance with applicable FDA, EU MDR, Health Canada, and other international regulatory requirements.
• Participate in audits, inspections, and regulatory inquiries related to complaint handling and post-market surveillance activities.

Risk Management and Corrective Actions

• Participate in product risk assessments associated with complaint investigations and post-market findings.
• Support the identification and escalation of significant quality and safety concerns.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, Engineering, and Technical Support teams to implement corrective and preventive actions (CAPAs).
• Verify implementation and effectiveness of assigned corrective actions.
• Ensure complaint information is appropriately incorporated into risk management and quality system processes
• Support the identification and escalation of significant quality and safety concerns.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, Engineering, and Technical Support teams to implement corrective and preventive actions (CAPAs).
• Verify implementation and effectiveness of assigned corrective actions.
• Ensure complaint information is appropriately incorporated into risk management and quality system processes.

Cross-Functional Collaboration

• Partner with Technical Support, Regulatory Affairs, Manufacturing, R&D, Engineering, and Operations teams to resolve product performance issues.
• Support investigations involving product failures, field issues, and customer concerns.
• Communicate investigation findings and recommendations to internal stakeholders.
• Contribute to continuous improvement initiatives related to complaint handling and post-market surveillance processes.

Quality Systems Support

• Maintain accurate and complete complaint records within the electronic Quality Management System (eQMS).
• Support internal audits, external audits, and regulatory inspections.
• Assist in the development and revision of complaint handling procedures, work instructions, and training materials.
• Ensure compliance with company quality policies and applicable regulatory requirements.

Other Responsibilities

• Participate in training and ongoing professional development related to complaint handling, post-market surveillance, and regulatory requirements.
• Support special projects and continuous improvement initiatives as assigned.
• Perform other duties as assigned.

Qualifications

• Bachelor’ Degree in Biology, Chemistry, Microbiology, Engineering or related discipline
• 2 to 5 years of experience in Complaint handling, Post-market surveillance, Quality Assurance, Regulatory Affairs, or related discipline
• Experience in regulated industry such as Medical device or other related field, preferred
• Knowledge of FDA Quality System Regulations, ISO 13485, EU MDR, and post-market surveillance requirements.
• Understanding of complaint handling, CAPA, risk management, and adverse event reporting processes.
• Familiarity with root cause analysis methodologies such as 5-Why, Fishbone Analysis, and Failure Mode and Effects Analysis (FMEA).
• Strong analytical and investigative skills.
• Proficiency with Microsoft Office applications and electronic Quality Management Systems (eQMS).
• Excellent written and verbal communication skills.
• Strong attention to detail and organizational abilities.
• Ability to manage multiple priorities and work effectively in a cross-functional environment.

Compensation Range: $90,000–$115,000/year