Medical Device Complaints Specialist - Generous Compensation

The Associate Compliant Management Specialist is responsible for supporting the required event reporting and investigation of all medical device complaint-related procedures.

Swing Shift:
8:30am - 4:30pm
OR
9:00am - 5:30pm

Pay Rate: 
$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