The Associate Compliant Management Specialist is responsible for supporting the required event reporting and investigation of all medical device complaint-related procedures.
Swing Shift : 8am - 4 : 30pm
8am - 4 : 30pm
9am - 5 : 30pm
Pay Rate : $25 / hr
$25 / hr
Job Description :
- Records and evaluates complaint submissions
- Communicates with territory managers and clinical specialists to acquire relevant complaint information
- Coordinates with internal departments (Customer Service, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing and R&D) to incorporate vital input into complaints reports
- Records and provides regulatory reportability decisions on complaints
- Ensures timely processing of complaints
- Generates and submits medical device event reports to appropriate authorities and government agencies as required by applicable laws and regulations
- Responds to inquiries regarding medical device report submission associated with device malfunction or serious injury
- Involved in activities to prepare for audits and inspections
- Receives returned goods and decontaminates if necessary
- Reviews and prepares complaint files for closure
- Participates in inter-departmental cross-functional projects
Position Qualifications :
- Knowledge of medical terms associated with sacral neuromodulation procedure and Medical Device Reporting regulations
- Exceptional organizational skills and attention to detail
- Able to perform job function with minimal supervision and work independently
- Display flexibility and a positive outlook in handling new processes, technology and general change
Minimum Education :
- Bachelor's degree or higher preferred
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