What are the responsibilities and job description for the Medical Device Complaint Specialist (Temporary) position at Prismatik?
Essential Functions:
- 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.
Education and Experience:
- 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.
Pay Range: $25.00 to $35.00/hr.
Salary : $25 - $35
