Regulatory Specialist, HeartFlow
$90-105k
Plus cash bonus and stock options
Medical equipment manufacturing
Be an early applicant
Medical equipment manufacturing
501-1000 employees
Be an early applicant
$90-105k
Plus cash bonus and stock options
501-1000 employees
Company mission
To save lives, improve the patient experience and reduce the overall costs of care.
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 was founded in 2007 and is a medical equipment manufacturer that uses CT-scanned 3D modelling to assess and analyze a patient's arteries. This noninvasive process can help assess the risks of heart disease and strategize the appropriate treatment.
HeartFlow has had a long history of awards and innovations. In 2021, it brought its technology to the NHS in England and in October 2022, introduced a plaque analysis service. As time has gone on, Heartflow has indicated that it is keeping up with technological advances and finding new ways to provide heart health services through them.
HeartFlow successfully launched its IPO in 2021 but faced a setback when its merger with Longview Acquisitions was called off in 2022 due to unfavourable market conditions. Despite this, the company has made a strong comeback and recently unveiled its next-generation plaque analysis AI, demonstrating its continued commitment to innovation and growth.
Steph
Company Specialist at Welcome to the Jungle
Insights
4% employee growth in 12 months
Company
Funding (last 2 of 10 rounds)
Apr 2023
$215m
SERIES F
Jun 2019
$65m
LATE VC
Total funding: $882.6m
Company benefits
- Medical, Dental, Health (90% of premium paid by HeartFlow)
- Stock options to all employees
- Flexible Spending Accounts
- Lounge featuring collaboration space, pinball, foosball, and ping pong
- Free snacks and drinks and subsidized health food
- Friday run/walk program - get fit, socialize and earn rewards
- Events throughout the year: Ironman competition, blood drive, sports league play (kickball, beach volleyball, etc), waffle bar, BBQs, biometrics assessment, and more!
Company HQ
Old Mountain View, Mountain View, CA
Leadership
John Farquhar
(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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