Principal Regulatory Affairs Lead, SaMD & AI

Regulatory Jobs; San Francisco (CA); On-site; USD 188,000 - 240,000; Full time

Job summary

Heartflow, a medical technology company in San Francisco, seeks a Principal Regulatory Affairs Specialist to drive global regulatory strategy for AI-driven SaMD products. You will partner with Software, Data Science and Quality teams from planning through global clearance and post-market activities.

The role requires 10+ years in regulatory affairs for medical devices, with 4+ years in SaMD, and strong leadership and communication skills to mentor team members and align cross-functional plans.

Qualifications

• Bachelor’s degree in Computer Science, Biomedical Engineering, Software Engineering or related field.
• 10+ years of direct Regulatory Affairs experience in medical devices, with at least 4+ years focused on SaMD/SiMD/digital health.
• Direct experience clearing or approving SaMD (510(k), De Novo, CE Mark) with FDA/EU Notified Bodies.

Responsibilities

• Lead global regulatory strategy and submissions for SaMD and AI/ML-enabled devices.
• Collaborate with Software, Data Science, Product Management and Quality teams from planning to post-market activities.
• Engage with FDA Digital Health Center of Excellence, Notified Bodies and third-party partners.
• Maintain regulatory pre-market and post-market commitments and support SOP development.

Skills

Regulatory strategy

Regulatory submissions

FDA/EU regulations

Regulatory intelligence

Leadership

Communication skills

Education

Bachelor’s degree

Master’s degree

PhD

Tools

IEC 62304

ISO 14971

IEC 82304-1

Job description

Heartflow, a medical technology company in San Francisco, seeks a Principal Regulatory Affairs Specialist to drive global regulatory strategy for AI-driven SaMD products. You will partner with Software, Data Science and Quality teams from planning through global clearance and post-market activities.

The role requires 10+ years in regulatory affairs for medical devices, with 4+ years in SaMD, and strong leadership and communication skills to mentor team members and align cross-functional plans.