Post Market and Complaint Analyst

Post Market and Complaint Analyst Job Locations

US-MA-North Billerica

Company Meridian Bioscience, Inc.

Department Quality & Regulatory Affairs

# of Openings 1 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... For full info follow application link.

We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.