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