Role: Remediation Complaint Analyst Role Summary The Remediation Complaint Analyst is part of the PMQA remediation team and supports the retrospective review of historical complaints. This includes assessment of complaints against the criteria prescribed by the applicable retrospective review protocol, documentation of results and escalation of issues identified.
Responsibilities Perform retrospective review and assessment of intake and complaint records per applicable retrospective review protocols.
Assess complaints to confirm the applicable complaint failure mode has been assigned, and escalate where the event relates to a potential adverse event.
Confirm that complaint investigations are best in class and aligned with requirements.
Confirm that complaints have been closed in a timely manner.
Provide input to the post-market surveillance organization on information gathered from complaint investigations.
Document results in accordance with the applicable retrospective review protocol.
Escalate to remediation clinical specialists or product quality engineers for correction as required.
Support the retrospective review and process remediation team as needed.
Communicate issues to the respective retrospective review lead.
Complete all assigned work in a timely manner.
Support FDA CAPA and intermediate controls as required.
Complete assigned training prior to performing assigned job responsibilities.
Participate in team meetings.
Support team leads and project managers with communication and reports needed for other forums.
Support the PMQA organization and remediation efforts as needed to ensure compliance to regulations and standards.
Qualifications Bachelor's degree or higher preferred, or an associate degree with five or more years of cradle-to-grave complaint handling experience.
Experience working in a medical device or pharmaceutical regulated environment.
Expertise in 21 CFR 820, 21 CFR 803, ISO 13485 and EU MDR.
Experience reviewing and assessing large quantities of complaints as part of a remediation project.
Experience with Microsoft Word, Excel and Teams, Agile, Salesforce or similar applications used in a medical device or pharmaceutical environment.
High level of attention to detail, with the ability to organize and manage multiple tasks.
Ability to spot consistent issues and escalate them to management, and to request feedback when unsure what action to take.
Good listening and communication skills, with the ability to stay on task and maintain timeline commitments.
Preferred Qualifications Knowledge of regulations impacting radiological devices and other integral regulations.