Complaint Specialist

Heartflow; Austin (TX); Hybrid; USD 61,000 - 75,000; Full time

Job summary

Heartflow is seeking a Complaint Specialist to protect patient safety and regulatory integrity of the Heartflow platform. You will manage the full lifecycle of product complaints, ensuring accurate evaluation, documentation, and timely regulatory reporting decisions in collaboration with cross-functional teams.

The role combines post-market surveillance with continuous quality improvement. A bachelor’s degree with 0–2 years’ experience in medical devices is expected, with hybrid work from

Qualifications

• Bachelor's degree required.
• 0-2 years' experience in medical device industry, preferably in complaint handling or post-market surveillance.
• Experience with software medical (Class II/III) preferred.

Responsibilities

• Assess and process complaints; ensure documentation and timely closure.
• Prepare regulatory reports (MDRs/vigilance) for FDA, EU, UK, and other authorities.
• Review investigations for completeness and root cause rationale; escalate safety signals as needed.
• Support trending, data requests, and quality system activities (CAPA, NCR, HHE).
• Collaborate with Customer Support and cross-functional partners on escalations.
• Help maintain complaint handling tools and streamline workflows.

Skills

Regulatory knowledge

Post-market surveillance

Risk management (ISO 14971)

Attention to detail

Communication skills

Independent work

Team collaboration

Salesforce experience

Education

Bachelor's degree

Tools

Salesforce

EDMS

Google Workspace

MS Office

Job description

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 FFRCT 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 (FFRCT 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 750,000 patients worldwide.

The Opportunity

As our Complaint Specialist, you will help protect the safety of patients and the regulatory integrity of the Heartflow platform after it reaches clinicians. You will manage product complaints from intake through closure, making sure every report is evaluated, documented, and assessed for reportability accurately and on time. This role is a core part of our post-market surveillance system and connects customer feedback to continuous quality improvement.

Job Description

The Complaint Specialist identifies, reviews, and processes complaints as required by applicable regulations, standards, and company procedures. Working closely with Senior Complaint Specialists, Customer Support, and cross-functional partners, you will make sure investigations are complete and well documented and that regulatory reporting decisions are properly justified.

Job 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.
• Regulatory Assessment: Perform and document regulatory reporting determinations. Prepare Medical Device Reports (MDRs) and vigilance reports for review and submission to FDA, EU, UK, and other global regulatory authorities as required.
• Investigation Review: Review complaint investigations for completeness, root cause rationale, and quality of documentation. Escalate potential safety signals when appropriate.
• Trending & Metrics Support: Assist with complaint data requests as needed to support trending and management review.
• Quality System Support: Support Quality Management System activities, including CAPA, Nonconformance Reports (NCR), Health Hazard Evaluations (HHE), risk management, and internal and external audits.
• Cross-Functional Liaison: Partner with Customer Support and serve as a liaison for complaint escalations, including clarifying event details and gathering additional information.
• Process Optimization: Help maintain complaint handling tools and procedures and find ways to streamline workflows as the business scales.

Skills Needed

• Working knowledge of US and international post-market requirements, including FDA Quality Management System Regulation (21 CFR 820, incorporating ISO 13485), 21 CFR 803, 21 CFR 806, EU MDR, UK MDR 2002, Health Canada Medical Devices Regulations, and Japan PMD Act
• Knowledge of ISO 14971 (risk management for medical devices)
• Strong critical thinking skills and great attention to detail
• Excellent communication, documentation, and time management skills
• Ability to work independently in a fast-paced, adaptive environment and to collaborate well within a team.
• Experience with Salesforce, Electronic Document Management Systems (EDMS), Google Workspace, and MS Office

Educational Requirements & Work Experience

• Education: Bachelor's degree
• Experience: 0-2 years of relevant experience in the medical device industry, preferably in complaint handling or post-market surveillance Experience with software medical (Class II/III) preferred.

This position follows a hybrid schedule requiring the employee to work from: Austin, TX Office: Four times per week

This position has an estimated base salary of $61,000 to $75,000 and bonus. ;

Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.

Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.