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Complaint Lead

3 months ago

Irvine, United States PRISMATIK DENTALCRAFT, INC. Full time

Prismatik Dentalcraft is a division of Glidewell Dental.


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.


Pay: $35.00-$45.00/hr.