Senior Manager, Quality System & Compliance

The posting, as Heartflow wrote it

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 FFR CT 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 (FFR CT 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.

Job Responsibilities

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

[…]
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.

This position has an estimated base salary of $195,000 - $250,000, bonus, and equity. #LI-IB1; LI-Hybrid
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.

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/ .