Staff Regulatory Affairs Engineer (AI/ML SaMD)

Location: San Francisco, United States; hybrid

Salary: $168,000–$252,000 annual base salary, plus equity and benefits

Company

hirify.global develops software, including AI, to automate care for joint and muscle health, covering acute injury, chronic pain, and post-surgical rehabilitation.

What you will do

• Lead the planning, authorship, and submission of FDA 510(k), De Novo, and Q-Submissions for AI/ML-enabled Software as a Medical Device.
• Develop regulatory strategies for new products and major software updates, including adaptive algorithm validation and monitoring.
• Assess the regulatory impact of software, AI model, and retraining pipeline changes through design reviews and change control boards.
• Support the Quality Management System and ensure alignment with 21 CFR 820 and ISO 13485.
• Review labeling, marketing materials, and user manuals for substantiated claims and consistent indications for use.
• Lead post-market complaint assessments, regulatory reporting, recalls, and field actions related to AI model performance.

Requirements

• Bachelor’s degree in Biomedical Engineering, Software Engineering, Regulatory Science, or a related technical or scientific field.
• 4–6+ years of Regulatory Affairs experience in the medical device industry, including at least 3 years focused on SaMD or digital health.
• Proven experience authoring and clearing US FDA Class II 510(k) or De Novo submissions and communicating with FDA reviewers.
• Technical fluency in software architecture, cloud infrastructure, AI/ML concepts, IEC 62304, and FDA software validation guidance.
• Direct regulatory submission experience involving Machine Learning, Deep Learning, or Computer Vision, plus familiarity with GMLP and PCCP.
• Experience with international registrations such as EU MDR software CE Marking or Health Canada requirements, statistical analysis, clinical validation, and Agile/Scrum delivery.

Culture & Benefits

• Medical, dental, and vision coverage for employees and family members.
• Support for gender-affirming care, family and fertility planning, and travel reimbursement when healthcare is unavailable locally.
• Traditional or Roth 401(k) options with a 2% company match.
• Learning and development stipends.