Complaint Specialist

Summary

Join HeartFlow, a leading medical technology company, as a Complaint Specialist. You will play a critical role in reviewing complaints, ensuring thorough investigations and regulatory reporting. This position requires a strong understanding of medical device regulations and experience in complaint handling. Responsibilities include assessing customer feedback, documenting investigations, managing complaint records, and providing post-market metrics. The ideal candidate possesses strong communication, documentation, and time management skills, along with knowledge of relevant regulations. HeartFlow offers a competitive salary, bonus, and stock options.

Requirements

• Knowledge of US and International regulatory post-market requirements
• Critical thinking skills and great attention to detail
• Excellent communication, documentation and time management skills
• 2-5 years’ relevant experience in medical device industry or related experience

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, and Health Hazard Evaluation and Risk Management

Preferred Qualifications

• Experience with software medical device product
• Experience with EDMS - Electronic Document Management System
• Proficient with Salesforce platform
• Proficient with Windows, MS Office, Excel and PowerPoint skills
• Bachelor’s degree

Benefits

• Cash bonus
• Stock options