Complaint, Lead

3 weeks ago

Irvine, United States Prismatik Full time

**Essential Functions**:

- Leads the daily activities of the complaints department.
- Maintains QMS documentation required for complaint processing compliance with 21 CFR part 820.198 and MDSAP program.
- Organizes reporting of department operations to track department status.
- Files FDA Medical Device Reporting (MDR) and Health Canada incident reports.
- Evaluates event(s) to determine if it qualifies as a complaint.
- Maintains and completes complaint files for all customer complaints according to procedures.
- Assesses complaint information provided; conducts additional investigations and escalates complaint to appropriate parties as needed.
- Compiles adverse event investigation information; summarizes investigation, production analysis, imaging review, instructions for use (IFU), and other relevant labeling and/or training materials; formulates conclusions.
- Interfaces with customers and collaborates with various departments and management.
- Manages customer relationships and expectations during course of complaint investigation.
- Serves as resource for team members.
- Monitors complaints regulatory reporting requirements to ensure timeliness of submissions.
- Evaluates complaints for adverse event reporting as applicable.
- Verifies comprehensive content of draft MDR reports prior to submission of Form 3500A to FDA.
- Verifies decisions for "Vigilance report not required" and “MDR report not required” determinations.
- Closes complaint files when necessary.
- Reviews potential reportable events to determine if regulatory filings are required.
- Submits Regulatory Reports for US and OUS.
- Ensures compliance with all federal and international regulations applicable to manufactured medical devices.
- Coordinates escalation to Medical Reviewer(s) for decisions regarding potential for serious injuries based on assessed risks.
- Escalates complaints when new failure modes are encountered.
- Maintains awareness of new products and government regulations and requirements.
- Documents and completes complaints in timely manner.
- Prepares and submits final customer correspondence as required.
- Performs other related duties and projects as business needs require at direction of management.

**Education and Experience**:

- Bachelor’s degree in science, engineering, or equivalent relevant experience preferred.
- Minimum five (5) years of experience within regulatory affairs or medical documentation and reporting.
- Advanced medical device experience involving medical device complaint files and quality records required.

**Pay: $35-$45/hr

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