Complaint Specialist

Prestigious billion dollar medical device company targeting a Complaint Specialist to join the team!*Role is temp 3-6 months with potential to be hired on full time Hybrid schedule, Monday and Thursday onsite Irvine. Start time flex 7am-9amComp $30-$40/hr*Must have:Medical Device Class III, or Dental experienceComplaint Specialist experience – process medical complaints specific to medical deviceExplain in detail ISO 13485DUTIES:Evaluates event(s) to determine if it qualifies as a complaint.Assesses complaint information provided, gather any missing information for complainant file, and escalates complaint to appropriate parties as needed.Manages customer relationship and expectations during course of complaint investigation and resolution process.Reviews potential reportable events to determine if regulatory filings are required.Ensures compliance with all federal and international regulations applicable to manufactured medical devices.Maintains and completes complaint files for all customer complaints according to procedures.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.Minimum Qualifications: Bachelor’s degree in science, engineering, or equivalent relevant experience preferred.Minimum two (2) years of experience within regulatory affairs or medical device reporting.Medical device experience preferred.Understanding and interpretation of domestic and international complaint handling and reporting requirements required.