Principal Regulatory Affairs Specialist (AI/ML Medical Devices)

Location: San Francisco, California or Rohnert Park, California, United States

Base salary: $188,000–$240,000 per year, plus bonus and equity.

Company

hirify.global is a publicly traded medical technology company developing AI-driven, non-invasive solutions for diagnosing and managing coronary artery disease.

What you will do

• Represent Regulatory Affairs on cross-functional product development teams and align regulatory deliverables with business objectives.
• Author and execute global regulatory strategies for FDA Pre-submissions, 510(k)s, De Novo requests, EU MDR CE Marking, and other markets.
• Develop submission strategies for AI/ML-enabled medical devices, Good Machine Learning Practice, and Predetermined Change Control Plans.
• Lead communications with the FDA Digital Health Center of Excellence, Notified Bodies, and third-party partners.
• Maintain pre-market and post-market regulatory commitments, support quality-system activities, and assess software changes for filing requirements.
• Track digital health regulations and standards while mentoring software engineers, product managers, and junior regulatory specialists.

Requirements

• Bachelor’s degree in Computer Science, Biomedical Engineering, Software Engineering, Electrical Engineering, or a related scientific field.
• 10+ years of direct Regulatory Affairs experience in medical devices, including 4+ years focused on SaMD, SiMD, or complex digital health solutions with AI/ML.
• Direct experience successfully clearing or approving SaMD applications through the FDA and/or EU Notified Bodies.
• Knowledge of IEC 62304, ISO 14971, and IEC 82304-1.
• Ability to translate complex software engineering concepts into clear regulatory rationale and work effectively with minimal oversight.
• Work location is San Francisco or Rohnert Park, California.

Nice to have

• Direct experience submitting Predetermined Change Control Plans for AI/ML algorithms.
• Knowledge of clinical trial strategy and clinical study design.
• Six or more years of experience with a Master’s degree, or four or more years with a PhD.

Culture & Benefits

• Bonus and equity are included in the compensation package.
• Work with software engineering, data science, product management, clinical, and quality functions.
• Support an inclusive workplace that respects and supports individuals without discrimination.
• Contribute to medical products used by more than 750,000 patients worldwide.