What are the responsibilities and job description for the Complaint, Lead (Monday to Friday 7:00am to 4:00pm) position at Prismatik?
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.
- Serves as subject matter expert (SME) of Quality Systems for complaint handling and regulatory reporting.
- 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.
Salary : $35 - $45
