Senior Manager, SaMD QMS & Regulatory Compliance

Heartflowinc; San Francisco (CA); Hybrid; USD 195,000 - 250,000; Full time

Benefits offered by this job

Bonus

Equity

Job summary

Heartflow is seeking a Senior Manager of Quality System and Regulatory Compliance to lead and mature its QMS across global markets, focusing on SaMD and SaaS aspects within the medical device space.

You will guide regulatory submissions, audits, and continuous improvement, building a high-performing quality organization that partners with R&D, Production, Regulatory, and Clinical teams to balance compliance with business objectives.

Qualifications

• Bachelor's degree in engineering or scientific discipline.
• 10+ years of progressive experience in Quality within the medical device industry.
• Proven leadership experience in quality management and regulatory inspections (FDA, Notified Bodies).

Responsibilities

• Oversee the Quality Management System (QMS) to ensure compliance with FDA, ISO 13485, EU MDR, and MDSAP across global operations.
• Serve as SME during audits by FDA, Notified Bodies, and other regulators; prepare organization for compliance.
• Lead, mentor, and scale a high-performing QMS team and collaborate with R&D, Production, Regulatory, Clinical, and Product teams.

Skills

Quality Management

Audits

Regulatory Compliance

Leadership

Communication

Education

Bachelor's degree in engineering or scientific discipline

10+ years in medical device quality

Job description

Heartflow is seeking a Senior Manager of Quality System and Regulatory Compliance to lead and mature its QMS across global markets, focusing on SaMD and SaaS aspects within the medical device space.

You will guide regulatory submissions, audits, and continuous improvement, building a high-performing quality organization that partners with R&D, Production, Regulatory, and Clinical teams to balance compliance with business objectives.