Senior Complaint Specialist, HeartFlow
$75-100k
+ Bonus
Medical equipment manufacturing
Open for applications
Medical equipment manufacturing
501-1000 employees
Open for applications
$75-100k
+ Bonus
501-1000 employees
Company mission
To establish a new era of personalized care by delivering AI-driven analysis and insights to proactively manage CAD for life.
Role
Who you are
- 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
- 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
What the job involves
- 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
- 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
- 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
Our take
HeartFlow is a medical equipment manufacturer that uses CT-scanned 3D modelling to assess and analyze a patient's heart and arteries. This non-invasive process can help assess the risks of Coronary Artery Disease (CAD) and strategize the appropriate treatment.
As the world’s leading cause of death, CAD is a worthy target for improved diagnosis and treatment. HeartFlow's approach enables clinicians to deliver more effective treatments faster, making CAD more manageable than ever before.
The company has a long history of awards and innovations, adopting technological advancements as they happen. It successfully launched its IPO in 2021, although a 2022 merger with Longview Acquisitions was called off due to unfavourable market conditions. Despite this, the company remains steadfast, unveiling new technology that ensures better treatment for CAD patients.
Steph
Company Specialist at Welcome to the Jungle
Insights
4% employee growth in 12 months
Company
Funding (last 2 of 11 rounds)
Mar 2025
$98m
CONVERTIBLE
Apr 2023
$215m
SERIES F
Total funding: $980.6m
Company benefits
- Medical / Dental / Vision (90% of premium paid by Heartflow)
- Flexible Spending and Health Savings Accounts
- 401k plan with employer match
- Company holidays
- Paid sick time and vacation
- Parental leave
- EAP Program
- Free snacks and drinks
- Fitness competition, Blood drive, Waffle Wednesdays and more!
Company HQ
Old Mountain View, Mountain View, CA
Leadership
John Farquhar
(President & CEO)Joined HeartFlow in 2021 as the President and Chief Operating Officer and became the CEO in 2022. Prior to this, they were the VP and General Manager at Medtronic. They also spent 5 years as a Professional Football Player in the NFL.
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