Regulatory Specialist, HeartFlow

$90-105k

Plus cash bonus and stock options

Excel

Junior and Mid level

Remote from US

Medical equipment manufacturing

Job no longer available

Medical equipment manufacturing

501-1000 employees

RetailB2BArtificial IntelligenceManufacturingDeep TechData AnalysisMedTech

Job no longer available

$90-105k

Plus cash bonus and stock options

Excel

Junior and Mid level

Remote from US

501-1000 employees

RetailB2BArtificial IntelligenceManufacturingDeep TechData AnalysisMedTech

Company mission

To establish a new era of personalized care by delivering AI-driven analysis and insights to proactively manage CAD for life.

Job

Company

Role

Who you are

The individual has 1-3 years of experience in Regulatory with an understanding of regulatory requirements and is able to resolve a wide-range of issues while maintaining compliance to regulations and standards
Base knowledge of global regulatory requirements
Project management skills a plus
Demonstrated team collaboration
Excellent communication, writing, and editing skills
Strong Word, Excel, and PowerPoint skills
Bachelor’s degree
1-3 years of experience in Regulatory Affairs
Software medical device experience a plus

What the job involves

The Regulatory Affairs Specialist is part of the Quality and Regulatory Affairs team
This individual will play a key role in HeartFlow regulatory activities involving cross-functional collaboration for product changes, as well as maintenance of key regulatory documentation
Support frequent mior software releases by performing change assessments
Support EU MDR application and maintenance of technical documentation, including clinical evaluation
Collaborate with cross-functional teams to drive regulatory project management activities
Manage timely completion of new product registrations and maintain global regulatory approvals to market software devices
Collaborate with external partners including regulatory agencies, authorized representatives, importers and distributors
Gain experience with US FDA submissions
Provide input to the risk management process to ensure risks are identified and updated during the product life-cycle
Conduct regulatory surveillance and communicate changes in regulations., standards, and guidances
Support Quality System management, as needed
Other relevant duties as assigned
Ability to work in a fast-paced adaptive environment, self-starter, and strong team player

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

Top investors

4% employee growth in 12 months

Glassdoor (2.8)

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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