Complaint Specialist
About the job
- Working knowledge of United States 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 for medical-device risk management.
- Strong critical thinking and attention to detail.
- Excellent communication, documentation, and time management skills.
- Ability to work independently in a fast-paced, adaptive environment and collaborate within a team.
- Experience with Salesforce, Electronic Document Management Systems (EDMS), Google Workspace, and Microsoft Office.
- Bachelor's degree.
- 0–2 years of relevant experience in the medical device industry.
- Assess reports received through multiple customer feedback channels to identify alleged deficiencies, ensure accurate documentation, and manage timely complaint review and closure.
- Perform and document regulatory reporting determinations; prepare Medical Device Reports (MDRs) and vigilance reports for review and submission to the FDA, European Union, United Kingdom, and other global regulatory authorities as required.
- Review complaint investigations for completeness, root-cause rationale, and documentation quality; escalate potential safety signals when appropriate.
- Assist with complaint data requests to support trending and management review.
- Support Quality Management System activities, including CAPA, Nonconformance Reports (NCR), Health Hazard Evaluations (HHE), risk management, and internal and external audits.
- Partner with Customer Support and serve as a liaison for complaint escalations, including clarifying event details and gathering additional information.
- Help maintain complaint-handling tools and procedures and identify ways to streamline workflows as the business scales.
- Experience in complaint handling or post-market surveillance is preferred.
- Experience with software medical devices (Class II/III) is preferred.
About the company
HeartFlow provides a non-invasive cardiac test that helps doctors visualize a patient’s coronary arteries to diagnose and plan treatment for heart disease. It uses a proprietary set of analyses—FFRCT Analysis, RoadMap Analysis, Plaque Analysis, and HeartFlow Planner—to create a detailed, patient-specific visualization from imaging data, enabling clinicians to assess blood flow and plaque without surgery. This approach reduces the need for invasive procedures, lowers risk for patients, and can cut costs for healthcare providers. Compared with traditional methods, HeartFlow offers validated, FDA-cleared tools that integrate multiple analyses into one platform, giving physicians a clearer, data-driven basis for diagnosis and treatment decisions. The company’s goal is to improve cardiovascular care by making safer, more efficient diagnosis and treatment planning widely available in hospitals and clinics around the world.
Company Size
501-1,000
Company Stage
IPO
Headquarters
San Francisco, California
Founded
2010
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Simplify's Take
What believers are saying
- Q2 2026 revenue rose 48% to $64.1 million, lifting full-year guidance.
- Plaque revenue reached $7.8 million in Q2 2026, becoming a second growth engine.
- Gross margin hit 83%, showing strong operating leverage and software economics.
What critics are saying
- Cleerly’s July 2026 plaque clearance and FFR-CT code pressure HeartFlow pricing power.
- The April 2026 Texas patent suit against Cleerly drains management time and cash.
- Growth depends on reimbursement and clinician adoption; any payer pullback hits 2027 revenue fast.
What makes HeartFlow unique
- HeartFlow One unifies FFRCT, Plaque Analysis, and PCI Navigator in one workflow.
- July 2026 Plaque Staging uses total plaque volume with up to 16 years follow-up.
- HeartFlow holds the only FDA-cleared AI plaque tool with reported 95% IVUS agreement.
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Benefits
Remote Work Options
Stock Options
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Growth & Insights and Company News
6 month growth
↑ 0%1 year growth
↑ 0%2 year growth
↑ 1%HeartFlow CEO John C.M. Farquhar sold 38,900 shares of common stock for $1.8 million, according to a 14 September 2026 SEC filing. The shares were sold at a weighted average price of $46.78, with individual trades ranging from $45.43 to $47.78. The transaction was conducted under a Rule 10b5-1 trading plan established on 12 September 2025. Following the sale, Farquhar retains approximately 322,000 shares, representing 0.37% of the company, plus derivative securities. HeartFlow develops AI-powered cardiac diagnostic solutions that create three-dimensional digital replicas of patient hearts from CT scans. The company has a market capitalisation of $4.3 billion and generated $212.1 million in trailing 12-month revenue, whilst recording a net loss of $118.4 million.
HeartFlow's Chief Medical Officer Campbell Rogers sold 9,219 shares on 17 August 2026 for approximately $380,100, according to an SEC Form 4 filing. The transaction was executed under a Rule 10b5-1 trading plan adopted in December 2025. Rogers retains a significant stake in the company, holding 86,459 shares directly and 145,540 shares indirectly through various trusts, representing a 0.27% ownership. He also maintains 82,972 options vesting monthly through August 2029. HeartFlow's shares closed at $45.23 on 18 August 2026, achieving a 35% one-year return as of the transaction date. The company, which develops AI-powered cardiac diagnostic solutions, has a market capitalisation of $3.9 billion with trailing twelve-month revenue of $212.1 million and a net loss of $118.4 million.
Heartflow reported second quarter 2026 revenue of $64.1 million, up 48% year-over-year, driven by increased US case volumes for its FFRCT and Plaque products. The AI-powered coronary artery disease diagnostics company posted a gross margin of 83.0% and a net operating loss of $17.9 million. The company raised its full-year revenue guidance to $246 million to $250 million, representing approximately 40% to 42% growth, up from previous guidance of $228 million to $232 million. It also increased its non-GAAP gross margin outlook to approximately 82% from 81%. CEO John Farquhar said the Plaque product is emerging as a "meaningful second growth engine" alongside the core FFRCT business, helping win new accounts and deepen physician utilisation.
HeartFlow reported second quarter 2026 revenue of $64.1 million, up 48% year over year. US revenue grew 51% to $59.6 million, marking the company's fastest growth in eight quarters. The medical technology firm's Plaque product generated $7.8 million in revenue, exceeding expectations. Total global revenue cases reached 84,491, up 74% year over year. Gross margin expanded to 83.3% from 75.6% in the prior year period, driven by AI efficiencies and higher-margin Plaque mix. HeartFlow raised its full-year 2026 revenue guidance to $246 million to $250 million, representing 40% to 42% growth. The company also increased its Plaque revenue outlook to $29 million to $31 million. The non-GAAP operating loss narrowed to $7.9 million from $11.5 million last year. HeartFlow ended the quarter with $246.8 million in cash and investments.
Heartflow (NASDAQ:HTFL) shares gap up following better-than-expected earnings. August 14, 2026 Key points. * Heartflow shares surged after the company reported adjusted EPS of $(0.07), beating estimates of $(0.22), while quarterly revenue reached $64.08 million, up 47.7% year over year. * The stock opened at $39.06 versus a prior close of $31.01 and last traded near $41.07, above the analyst consensus target of $38.86. * Analysts maintain a generally positive outlook, with MarketBeat reporting a "Moderate Buy" consensus, although insiders have sold 115,805 shares worth approximately $3.53 million over the past three months. * Interested in Heartflow? Here are five stocks we like better. Heartflow, Inc. (NASDAQ:HTFL - Get Free Report) shares gapped up prior to trading on Friday following a stronger than expected earnings report. The stock had previously closed at $31.01, but opened at $39.06. Heartflow shares last traded at $41.0730, with a volume of 1,793,589 shares changing hands. The company reported ($0.07) EPS for the quarter, beating analysts' consensus estimates of ($0.22) by $0.15. The company had revenue of $64.08 million for the quarter. The company's revenue for the quarter was up 47.7% on a year-over-year basis. Wall Street analyst weigh in. A number of research firms have recently commented on HTFL. Piper Sandler reissued an "overweight" rating on shares of Heartflow in a research note on Friday. Canaccord Genuity Group decreased their target price on Heartflow from $43.00 to $37.00 and set a "buy" rating for the company in a research note on Friday, May 15th. Freedom Capital upgraded shares of Heartflow to a "strong-buy" rating in a research report on Tuesday, June 30th. William Blair started coverage on shares of Heartflow in a report on Monday, May 4th. They issued an "outperform" rating for the company. Finally, Weiss Ratings raised shares of Heartflow from a "sell (e+)" rating to a "sell (d-)" rating in a research note on Friday, August 7th. One analyst has rated the stock with a Strong Buy rating, eight have given a Buy rating, two have assigned a Hold rating and one has issued a Sell rating to the stock. According to data from MarketBeat, Heartflow presently has an average rating of "Moderate Buy" and an average target price of $38.86. Insider buying and selling at Heartflow. In other news, CEO John C.M. Farquhar sold 22,562 shares of the company's stock in a transaction on Monday, August 10th. The stock was sold at an average price of $28.31, for a total transaction of $638,730.22. Following the completion of the sale, the chief executive officer directly owned 436,280 shares of the company's stock, valued at $12,351,086.80. This represents a 4.92% decrease in their ownership of the stock. The sale was disclosed in a document filed with the SEC, which is available at the SEC website. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Also, insider Campbell Rogers sold 9,219 shares of the stock in a transaction on Monday, May 18th. The shares were sold at an average price of $28.34, for a total value of $261,266.46. Following the completion of the transaction, the insider owned 78,731 shares of the company's stock, valued at $2,231,236.54. This trade represents a 10.48% decrease in their position. The disclosure for this sale is available in the SEC filing. The transaction was executed under a pre-arranged Rule 10b5-1 trading plan. Over the last three months, insiders have sold 115,805 shares of company stock valued at $3,530,609. Corporate insiders own 7.70% of the company's stock. Institutional trading of Heartflow. A number of hedge funds have recently bought and sold shares of HTFL. TrueMark Investments LLC raised its holdings in shares of Heartflow by 1.4% during the first quarter. TrueMark Investments LLC now owns 26,885 shares of the company's stock valued at $654,000 after acquiring an additional 379 shares during the period. Caitong International Asset Management Co. Ltd purchased a new position in Heartflow during the 4th quarter worth approximately $27,000. Strs Ohio grew its position in Heartflow by 35.3% during the 1st quarter. Strs Ohio now owns 4,600 shares of the company's stock worth $112,000 after purchasing an additional 1,200 shares in the last quarter. Russell Investments Group Ltd. acquired a new stake in Heartflow during the 4th quarter valued at $45,000. Finally, Legal & General Group Plc purchased a new stake in shares of Heartflow in the third quarter valued at $59,000. Heartflow price performance. The company has a market cap of $3.52 billion and a PE ratio of -13.18. The stock has a fifty day moving average price of $28.80 and a 200-day moving average price of $27.70. Heartflow company profile. HeartFlow, Inc NASDAQ: HTFL is a medical technology company that develops non-invasive diagnostic solutions for coronary artery disease. The company's core offering translates coronary CT angiography (CTA) data into a patient-specific, three-dimensional physiological model of the coronary arteries. Using advanced image processing and computational modeling, HeartFlow's analysis estimates fractional flow reserve (FFR) values throughout the coronary tree to identify ischemia-producing lesions without the need for invasive pressure-wire measurements. HeartFlow's cloud-based service integrates with clinical workflows: clinicians submit coronary CTA images and receive a detailed, color-coded 3D map and report that highlights lesion-specific FFR values and physiological impact. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. 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