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About the Role
Heartflow is a medical technology company dedicated to advancing the diagnosis and management of coronary artery disease. We utilize cutting-edge AI-driven technology to provide non-invasive cardiac tests that help clinicians identify and assess heart conditions. Join us in revolutionizing precision heartcare.
Responsibilities
- Lead clinical quality and regulatory compliance strategies for clinical programs.
- Ensure clinical trial compliance with FDA GCP guidelines and ISO 14155.
- Oversee medical device labeling requirements for investigational and post-market devices.
- Author and maintain Investigator’s Brochures (IB) for investigational medical devices.
- Lead Bioresearch Monitoring (BIMO) audit preparation, internal GCP audits, vendor oversight, and external inspections.
- Collaborate with Clinical Operations and CRO teams to ensure regulatory and quality standards.
- Establish clinical trial monitoring protocols and oversee key deliverables like ICFs, monitoring plans, and TMF quality.
- Partner with Clinical Operations to review regulatory document packages for site approvals and IRB/EC compliance.
- Manage regulatory compliance for Unanticipated Adverse Device Effects (UADE) and Serious Adverse Event (SAE) reporting.
- Implement oversight for logging, evaluating, and mitigating protocol deviations and non-compliance.
- Establish quality oversight and compliance metrics with Clinical Operations for field monitors and study personnel.
- Partner with Regulatory Affairs to ensure post-market regulatory obligations are met.
- Contribute to FDA Investigational Device Exemption (IDE) regulatory strategies and submissions.
- Navigate geographic data governance, data privacy, and cross-border clinical regulatory requirements.
- Participate in and lead process improvement activities.
- Perform other duties as necessary.
Requirements
- Deep technical knowledge of FDA IDE regulations, FDA GCP standards, ISO 14155, and medical device labeling requirements.
- Strong experience partnering with internal Clinical Operations teams to ensure GCP compliance.
- Direct hands-on experience hosting FDA BIMO audits and preparing for regulatory inspections.
- Demonstrated expertise reviewing and managing ICFs, IBs, IFUs, PMCF plans, and PSUR compilation.
- Extensive background managing protocol deviations, CAPA systems, and UADE/SAE safety reporting.
- Understanding of multi-geographic clinical trial execution, data integrity, and cross-border regulatory considerations.
- Strong matrix leadership and collaboration skills.
- Incredible attention to detail, accuracy, and quality.
- Ability to manage multiple tasks and work in an environment with shifting priorities.
- Ability to work in a collaborative team environment with a willing, all-hands-on-deck attitude.
- Excellent written and oral English communication skills.
- Proficiency in Microsoft Office tools (Word, Excel, PowerPoint) and Google tools.
Skills
- FDA IDE regulations
- FDA GCP standards
- ISO 14155
- Medical device labeling
- Clinical Operations collaboration
- GCP compliance
- BIMO audit hosting
- Regulatory inspection preparation
- ICF management
- IB management
- IFU management
- PMCF plan management
- PSUR compilation
- Protocol deviation management
- CAPA systems
- UADE/SAE safety reporting
- Multi-geographic clinical trial execution
- Data integrity
- Cross-border regulatory considerations
- Matrix leadership
- Collaboration
- Attention to detail
- Task management
- Adaptability
- Teamwork
- Written communication
- Oral communication
- Microsoft Office Suite
- Google Workspace
Location
- Remote
Work Type
- Hybrid
- Full-time
Experience Level
- 8+ years relevant experience in clinical quality assurance and regulatory affairs within the medical device, biotech, or combination product industries.
- Demonstrated experience leading BIMO audit readiness and FDA IDE submissions preferred.
- Proven track record of working in close alignment with internal Clinical Operations teams.
- Experience managing CROs and clinical vendors required.
Education Level
- Bachelor’s degree in Life Sciences, Biomedical Engineering, Clinical Research, or related scientific/health field (Master's, Ph.D., PharmD, or RN preferred).
Salary/Compensations
- $215,000 to $270,000
- cash bonus
- equity
About the Company
- Heartflow is a medical technology company advancing the diagnosis and management of coronary artery disease, the #1 cause of death worldwide, using cutting-edge technology.
- The flagship product—an AI-driven, non-invasive cardiac test supported by the ACC/AHA Chest Pain Guidelines 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 publicly traded company (HTFL) 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 750,000 patients worldwide.
Equal Opportunity
- Heartflow is an Equal Opportunity Employer. We are committed to a work environment that supports, inspires, and respects all individuals and do not discriminate against any employee or applicant because of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. This policy applies to every aspect of employment at Heartflow, including recruitment, hiring, training, relocation, promotion, and termination.