Complaint Specialist (Remote)

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Requirements:

• Knowledge of US and International regulatory post-market requirements
• Critical thinking skills and great attention to detail
• Experience with software medical device product preferred
• Experience with EDMS - Electronic Document Management System
• Excellent communication, documentation and time management skills
• Proficient with Salesforce platform preferred
• Proficient with Windows, MS Office, Excel and PowerPoint skills

Responsibilities:

• Assess reports received through multiple customer feedback channels to identify alleged deficiencies
• Ensure accurate documentation, evaluation, reporting determination and investigation results
• Post-market surveillance and vigilance reporting
• Manage timely and compliant complaint records review and closure
• Own the complaint tools and processes with a vision towards process improvement and streamlining
• Provide post-market metrics and data as needed
• Support Quality Management System, as needed
• Assist Customer Support and serve as a liaison for complaint escalations
• Review of complaint investigations and trends. General understanding of CAPA, NCR, Health Hazard Evaluation and Risk Management.