Senior Complaint Specialist

Join HeartFlow as a Senior Complaint Specialist, where you will play a critical role in ensuring the safety and regulatory integrity of our medical devices. You will be responsible for the end-to-end management of product complaints, regulatory reporting, data analysis, quality system support, field actions and recalls, cross-functional liaison, and process optimization. This role requires a deep understanding of medical device complaint handling processes and regulatory reporting procedures.

• End-to-end management of product complaints, ensuring technical accuracy and regulatory compliance.
• Timely and accurate Medical Device Reporting (MDR) and adverse event reporting to regulatory authorities.
• Collecting, evaluating, and analyzing complaints data to identify trends, potential risks, and opportunities for product improvement.
• Ability to stay current with global regulatory requirements and industry best practices
• Strong critical thinking skills and great attention to detail
• Proficient with Salesforce, Tableau, Electronic Document Management Systems (EDMS), Google Workspace, and MS Office
• Regulatory Knowledge and deep understanding of 21 CFR 820, 21 CFR 803, 21 CFR 806, EU MDR, Health Canada MPR, ISO13485, and ISO 14971
• Ability to work as a self-starter in a fast-paced, adaptive environment and mentor team members
• Excellent communication, documentation, and time management skill
• Experience: 5+ years of relevant experience in the medical device industry, software medical device products (class II/III) preferred
• Education: Bachelor’s degree in Science, Engineering, or a related field