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About the Role
As a Complaint Specialist, you will manage product complaints from intake through closure, ensuring accurate evaluation, documentation, and timely assessment for reportability. This role is crucial to our post-market surveillance system, connecting customer feedback to continuous quality improvement and protecting patient safety and regulatory integrity.
Responsibilities
- Identify, review, and process complaints according to regulations, standards, and company procedures.
- Ensure complaint investigations are complete and well-documented.
- Justify regulatory reporting decisions.
- Assess reports from customer feedback channels to identify alleged deficiencies.
- Manage timely complaint review and closure.
- Perform and document regulatory reporting determinations.
- Prepare Medical Device Reports (MDRs) and vigilance reports for submission to global regulatory authorities.
- Review complaint investigations for completeness, root cause rationale, and documentation quality.
- Escalate potential safety signals as needed.
- Assist with complaint data requests to support trending and management review.
- Support Quality Management System activities, including CAPA, NCR, HHE, risk management, and audits.
- Partner with Customer Support and serve as a liaison for complaint escalations.
- Clarify event details and gather additional information.
- Help maintain complaint handling tools and procedures.
- Identify opportunities to streamline workflows as the business scales.
Requirements
- 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.
- Great attention to detail.
- Excellent communication skills.
- Excellent documentation skills.
- Excellent time management skills.
- Ability to work independently in a fast-paced, adaptive environment.
- Ability to collaborate well within a team.
- Experience with Salesforce.
- Experience with Electronic Document Management Systems (EDMS).
- Experience with Google Workspace.
- Experience with MS Office.
Skills
- Post-market requirements
- FDA Quality Management System Regulation
- ISO 13485
- 21 CFR 803
- 21 CFR 806
- EU MDR
- UK MDR 2002
- Health Canada Medical Devices Regulations
- Japan PMD Act
- ISO 14971
- Risk management
- Critical thinking
- Attention to detail
- Communication
- Documentation
- Time management
- Independent work
- Team collaboration
- Salesforce
- EDMS
- Google Workspace
- MS Office
Location
- Austin, TX
Work Type
- Hybrid
Experience Level
- 0-2 years
Education Level
- Bachelor's degree
Salary/Compensations
- $61,000 to $75,000
About the Company
- 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.
Equal Opportunity
- 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.