Post Market Complaint Analyst - Pharma

Job Summary

The Complaint Analyst will support the Post Market Quality Assurance (PMQA) Remediation team in conducting retrospective reviews of historical complaint records. This role is responsible for assessing complaint files against established retrospective review protocols, documenting findings, identifying gaps or issues, and escalating concerns as needed to support remediation and compliance activities.

The ideal candidate will have experience in complaint handling, post-market surveillance, quality systems, CAPA, and medical device regulatory compliance.

Essential Duties & Responsibilities

· Perform retrospective review and assessment of complaint intake records and complaint files in accordance with applicable retrospective review protocols.

· Evaluate complaint records to ensure appropriate complaint failure modes have been assigned and properly documented.

· Identify and escalate complaints related to Potential Adverse Events (PAE) when applicable.

· Review complaint investigations to ensure completeness, quality, and alignment with regulatory and internal requirements.

· Verify complaint investigations are conducted and closed within required timelines.

· Document review findings and assessment results according to established remediation and retrospective review procedures.

· Provide input and feedback to the Post Market Surveillance (PMS) organization regarding trends, findings, and information gathered during complaint investigations.

· Escalate issues requiring correction or further investigation to Clinical Specialists, Product Quality Engineers, or appropriate remediation teams.

· Support Retrospective Review and Process Remediation activities as required.

· Communicate identified issues, risks, or concerns to Retrospective Review Leads and project stakeholders.

· Complete assigned deliverables and remediation activities within established timelines.

· Support FDA CAPA activities and intermediate control processes as required.

· Complete all required training prior to performing assigned responsibilities.

· Participate in team meetings, remediation discussions, and project reviews.

· Support Team Leads and Project Managers with reports, documentation, and communication activities.

· Assist PMQA and remediation teams in ensuring compliance with FDA regulations, quality standards, and internal procedures.

Required Qualifications

· Experience in complaint handling, complaint investigations, or post-market quality within the medical device industry.

· Understanding of FDA regulations, CAPA processes, and quality system requirements.

· Experience reviewing complaint files, investigation records, and remediation documentation.

· Strong attention to detail and documentation skills.

· Ability to identify compliance gaps, inconsistencies, and escalation risks.

· Strong written and verbal communication skills.

· Ability to work in a cross-functional remediation environment with Quality, Regulatory, Clinical, and Engineering teams.

· Proficiency with quality systems and documentation tools.

Preferred Qualifications

· Experience supporting remediation, retrospective review, or FDA inspection-related activities.

· Experience with Potential Adverse Event (PAE) assessments.

· Familiarity with Post Market Surveillance (PMS) processes.

· Medical device industry experience preferred.