New · posted Oct 15
HeartFlow · Medical Devices
Senior Manager, Quality System & Compliance
- San Francisco, CA
- Hybrid
- Full-time
- Manager
Open until filled
The role
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.
As the Senior Manager of Quality System and Quality (Regulatory) Compliance, you are a pivotal leader responsible for the strategy, execution, and continuous improvement of our Quality Management System (QMS), oversight, and associated tools. You will lead our efforts to ensure robust compliance with national and international medical device regulations, including FDA, ISO 13485, EU MDR, and MDSAP. This role is a unique blend of strategic foresight and tactical leadership, requiring a deep expertise in QMS setup and management, particularly for Software as a Medical Device (SaMD), with ability to make thoughtful changes and enhance the overall QMS.
You will lead a high-performing team of quality professionals , championing a "Quality-first" culture and driving data-driven decisions. Your proven track record of navigating complex regulatory landscapes, including FDA, PMDA, IEC, EU MDR, and ISO regulations and standards, is essential to our success.
What you need
Educational Requirements & Work Experience
- Bachelor's degree in engineering or scientific discipline, or equivalent.
- 10+ years of progressive experience in Quality within the medical device industry, with at least 5+ years in a leadership/management role.
- Expert-level knowledge of relevant regulations and standards, including FDA 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971.
- Proven track record of successfully leading or playing a key SME role in regulatory inspections (FDA, Notified Body).
- Exceptional leadership and communication skills, with a demonstrated ability to influence and build consensus among cross-functional senior leaders.
Preferred:
- Direct experience with AI/ML-driven SaMD and cloud-based medical device platforms.
- Familiarity with medical device cybersecurity standards (e.g., AAMI TIR57) and data privacy regulations.
- Experience with global regulatory submissions (e.g., CE Marking, PMDA).
- Experience implementing and scaling quality processes in a fast-paced and growing environment.
Heartflow has become aware of a fraud where unknown entities are posing as Heartflow recruiters in an attempt to obtain personal information from individuals as part of our application or job offer process. Before providing any personal information to outside parties, please verify the following: A) all legitimate Heartflow recruiter email addresses end with “@heartflow.com” and B) the position described is found on our careers site at www.heartflow.com/about/careers/.
Skills Needed
- Effective, clear, and concise communication skills bringing clarity to complex topics across the leadership spectrum.
- Ability to coach, mentor, and drive a collaborative quality culture through influence.
- Deep understanding of Quality System and Quality Compliance.
- Experience interacting with auditors, including Notified Body auditors and FDA Investigators.
What you'll do
Quality Management System (QMS) Oversight
- Manage holistic aspects of the QMS to ensure compliance with global regulations, including FDA, ISO 13485, EU MDR, and MDSAP countries’ requirements.
- Oversee the following key QMS subsystems: CAPA subsystem, Document Control, Training, Management Review, Internal Audits, and External Audit management, QMS Tool Validation, and Supplier Management.
- Drive continuous improvement initiatives to enhance the efficiency and effectiveness of the QMS.
Quality Compliance & Audits
- Serve as the front room or backroom lead and the primary subject matter expert (SME) for the QMS during audits, including inspections by the FDA, Notified Bodies, and other regulatory authorities.
- Prepare the organization for an appropriate level of quality compliance to U.S. and international requirements to support Heartflow’s global expansion.
Strategic Leadership & Team Development
- Lead, mentor, and scale a team of QMS professionals, fostering career growth and technical excellence.
- Champion a "Quality-first" mindset throughout the organization, through collaboration and using impactful KPIs to drive accountability and data-driven decisions.
- Collaborate with leaders and partners in R&D, Production, Regulatory, Clinical, and Product Management to integrate quality processes seamlessly, balancing compliance with business objectives.
- Manage departmental resources, including headcount and long-term strategic planning.
Pay and benefits
$195,000 – $250,000 a year
Employer providedThis position has an estimated base salary of $195,000 - $250,000, bonus, and equity. ; LI-Hybrid
Bonus
Equity
Where you'll work
San Francisco, CAHybridOpen in Maps (opens in a new tab)
More jobs in San Francisco, CAEqual opportunity, accessibility and legal noticesHeartFlow's statements, word for word
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.
Positions posted for Heartflow are not intended for or open to third party recruiters / agencies. Submission of any unsolicited resumes for these positions will be considered to be free referrals.
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 45% above the US median for Quality Assurance roles at this level.
This roleEmployer provided
Manager roles in California25 roles publishing pay
Manager roles in the US105 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $195,000 | — | $250,000 |
| California (middle half) | $156,000 | $165,500 | $181,000 |
| All US (middle half) | $126,000 | $153,000 | $167,500 |
This role: HeartFlow's own published range. Comparisons: the base pay employers published on open Quality Assurance roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Assurance
The general path across 845 open Quality Assurance roles on Regulatory Jobs, with the titles they carry most. Not HeartFlow's own promotion track.
Career resources on Quality Assurance
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance13
- Collaboration and leadership13
- Quality systems and risk9
- Regulatory submissions4
- Documentation and SOPs3
- Investigations and CAPA2
- Lab testing and methods1
- Validation and qualification1
- Data and digital systems1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
- FDA21 CFR Part 820 (QMSR)(official source, opens in a new tab)FDA quality management system regulation for medical devices
- European UnionEU MDR (Regulation 2017/745)(official source, opens in a new tab)The EU Medical Device Regulation
- ISOISO 13485(official source, opens in a new tab)Quality management systems for medical devices
- ISOISO 14971(official source, opens in a new tab)Risk management for medical devices
- IECIEC 62304(official source, opens in a new tab)Software life cycle processes for medical device software
- FDA and partnersMDSAP(official source, opens in a new tab)The Medical Device Single Audit Program
Company hiring pulse
HeartFlow on Regulatory Jobs
- 5
- Open roles
- 5
- Distinct roles
- 1
- Locations
By discipline
- Quality3 60%
- Regulatory1 20%
- Compliance & Safety1 20%
By level
- Senior & Principal3 60%
- Director1 20%
- Manager1 20%
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Senior Manager, Quality System & Compliance at HeartFlow
Open until filled. $195K–$250K a year, employer provided.