Heartflow

Heartflow

Senior Complaint Specialist

Austin, Texas · Senior

Sponsorship not specified$75k-$100kDetected 64 days ago
Data AnalysisData VisualizationStakeholder ManagementSalesforceProcess ImprovementCustomer SupportFDA RegulatoryPharmacovigilanceMedical DevicesCommunicationCritical ThinkingTime ManagementMentoringMicrosoft Office

About the role

  • As our Senior Complaint Specialist, you will play a critical role in ensuring the safety and regulatory integrity of our products after they reach clinicians and patients.
  • You will be responsible for the end-to-end management of product complaints, ensuring that every report is handled with the highest level of technical accuracy and regulatory compliance.
  • This role is a key pillar of our post-market surveillance strategy, bridging the gap between customer feedback and continuous quality improvement.

Responsibilities

  • Complaint Handling: Assess reports received through multiple customer feedback channels to identify alleged deficiencies, ensure accurate documentation, and manage timely complaint review and closure.
  • Field Actions & Recalls: Provide support on product field action activities, including identification, risk assessment, stakeholder communication, and coordination of corrective actions.
  • Cross-Functional Liaison: Assist Customer Support and serve as a technical liaison for complaint escalations, providing support on complaint closure approvals; Provide guidance and mentorship to team members on process execution and regulatory requirements.
  • Proficient with Salesforce, Tableau, Electronic Document Management Systems (EDMS), Google Workspace, and MS Office

Requirements

  • This role will be responsible for identifying, reviewing, and processing complaints for evaluation as required by applicable regulations, standards, and company procedures.
  • Bachelor's degree in Science, Engineering, or a related field.

Skills

  • Regulatory Knowledge and deep understanding of 21 CFR 820, 21 CFR 803, 21 CFR 806, EU MDR, Health Canada MPR, ISO13485, and ISO 14971
  • Strong critical thinking skills and great attention to detail
  • Ability to work as a self-starter in a fast-paced, adaptive environment and mentor team members
  • Excellent communication, documentation, and time management skill
  • Ability to stay current with global regulatory requirements and industry best practices

Compensation

  • This position has an estimated base salary of $75,000 to $100,000 and bonus. #LI-IB1; #LI-Hybrid

Benefits

  • 5+ years of relevant experience in the medical device industry, software medical device products (class II/III) preferred.
  • This position has an estimated base salary of $75,000 to $100,000 and bonus. #LI-IB1; #LI-Hybrid

Company info

  • Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology.
  • The flagship product-an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines called the Heartflow FFR CT Analysis-provides a color-coded, 3D model of a patient's coronary arteries indicating the impact blockages have on blood flow to the heart.
  • Heartflow is the first AI-driven non-invasive integrated heart care solution across the CCTA pathway that helps clinicians identify stenoses in the coronary arteries (RoadMap™Analysis), assess coronary blood flow (FFR CT Analysis), and characterize and quantify coronary atherosclerosis (Plaque Analysis).
  • Our pipeline of products is growing and so is our team; join us in helping to revolutionize precision heartcare.
  • Heartflow is a publicly traded company (HTFL) that has received international recognition for exceptional strides in healthcare innovation, is supported by medical societies around the world, cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 500,000 patients worldwide.
  • The Opportunity
  • Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process.

Equal opportunity

  • Heartflow is an Equal Opportunity Employer.
  • Equal Opportunity Employer.
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This listing is sourced directly from Heartflow's careers page and normalized into a canonical job model.