Senior Complaint Specialist

Heartflowinc; Austin (TX); On-site; USD 75,000 - 100,000; Full time

Job summary

Heartflowinc is hiring for a Senior Complaint Specialist to oversee product complaint management and ensure compliance with global regulations. This role is critical for upholding safety standards and bridging customer feedback to quality improvement efforts. Candidates should have at least 5 years in the medical device industry and possess strong regulatory knowledge.

The estimated salary for this position ranges from $75,000 to $100,000, supplemented by a bonus. Heartflowinc values diversity and is committed to an inclusive work environment.

Qualifications

• 5+ years of relevant experience in the medical device industry, preferably with software medical device products (class II/III).

Responsibilities

• Manage product complaints and ensure regulatory compliance.
• Analyze complaint data for trends and risks.
• Prepare Medical Device Reporting (MDR) accurately.

Skills

Regulatory knowledge (21 CFR 820, 803, 806, EU MDR)

Proficient with Salesforce

Strong critical thinking skills

Excellent communication skills

Ability to work in a fast-paced environment

Education

Bachelor’s degree in Science, Engineering, or a related field

Tools

Salesforce

Tableau

MS Office

Google Workspace

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 FFRCTAnalysis—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 (RoadMapAnalysis), assess coronary blood flow (FFRCTAnalysis), 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

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.

Job Description

The Senior Complaint Specialist requires experience in the medical device industry with a clear understanding of medical device complaint handling processes, trending, and regulatory reporting procedures. This role will be responsible for identifying, reviewing, and processing complaints for evaluation as required by applicable regulations, standards, and company procedures. This role serves as a primary subject matter expert for complaint escalations and ensures that all reporting requirements to domestic and international regulatory authorities are completed accurately and on time.

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 Reporting: Ensure timely and accurate Medical Device Reporting (MDR) and adverse event reporting to external regulatory authorities as required to ensure compliance with global regulatory requirements, including but not limited to FDA (21 CFR 820, 803, 806) and EU MDR.
• Data Analysis & Statistical Trending: Collect, evaluate, and analyze complaints data to identify trends, potential risks, and opportunities for product improvement.
• Quality System Support: Provide support on the maintenance of department documents and procedures; participate in Quality Management System (QMS) activities and Risk Management activities, including Health Hazard Evaluations (HHE), CAPA, and Nonconformance Reports (NCR).
• 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.
• Process Optimization: Identify efficiencies in our surveillance workflows to scale our operations.

Skills Needed

• Regulatory knowledge and deep understanding of 21 CFR 820, 21 CFR 803, 21 CFR 806, EU MDR, Health Canada MPR, ISO13485, and ISO 14971.
• Proficient with Salesforce, Tableau, Electronic Document Management Systems (EDMS), Google Workspace, and MS Office.
• 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.

Educational Requirements & Work Experience

• Education: Bachelor’s degree in Science, Engineering, or a related field.
• Experience: 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.

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.