Senior Manager, Medical Affairs
Baxter InternationalSalary not specified
- Full Time
- Senior (5 to 8 years)
Not SpecifiedCompensation
Junior (1 to 2 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, Healthcare TechnologyIndustries
Position Overview
- Location Type: Remote
- Employment Type: Full-time
- Salary: Not specified
Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease using cutting-edge technology. The flagship product—an AI-driven, non-invasive cardiac test 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 VC-backed company 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 400,000 patients worldwide.
Job Responsibilities
- Support frequent minor 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
Skills Needed
- 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
Educational Requirements & Work Experience
- Bachelor’s degree
- 1-3 years of experience in Regulatory
Application Instructions
- #LI-Remote; #LI-IB1 (Likely indicates LinkedIn application and internal/diversity initiatives)
Skills
Regulatory Affairs
Medical Device Regulations
EU MDR
US FDA submissions
Regulatory Documentation
Risk Management
Regulatory Surveillance
Cross-functional Collaboration
HeartFlow
Non-invasive cardiac testing for heart disease
About HeartFlow
HeartFlow provides a non-invasive cardiac test that helps visualize a patient's coronary arteries in detail. This technology allows physicians to diagnose and treat heart disease more effectively without the need for invasive procedures, which reduces risks for patients and costs for healthcare providers. HeartFlow's main clients are healthcare professionals seeking safer diagnostic methods. The company offers several analyses, including FFRCT Analysis and Plaque Analysis, all of which have received FDA clearance and are available in multiple countries, including the United States, the United Kingdom, Japan, and Canada. Unlike many competitors, HeartFlow focuses on providing a comprehensive suite of analyses that enhance treatment planning. The goal of HeartFlow is to improve cardiovascular care by making it safer and more efficient for both patients and healthcare providers.
Redwood City, CaliforniaHeadquarters
2010Year Founded
$858.5MTotal Funding
SERIES_FCompany Stage
HealthcareIndustries
501-1,000Employees