Regulatory Compliance Lead (AI/MedTech)

TL;DR

Regulatory Compliance Lead (AI/MedTech): Developing and maintaining regulatory compliance frameworks for consumer, research, and SaMD products with an accent on AI/ML-enabled applications. Focus on operationalizing regulatory requirements within engineering workflows, managing submissions, and ensuring compliance with FDA and international standards.

Location: Must be based in the United States

Salary: $111,000 - $167,000

Company

hirify.global is a data platform and technology company building AI-enabled precision health solutions to accelerate research and improve patient care.

What you will do

• Develop and maintain regulatory compliance frameworks for consumer, research, and SaMD products.
• Partner with engineering and product teams to embed compliance into the product development lifecycle.
• Apply statistical methods to support regulatory decision-making and performance evaluation.
• Monitor evolving regulatory guidance, including FDA SaMD and AI/ML frameworks.
• Author and maintain regulatory documentation, including submissions and SOPs.
• Support post-market surveillance activities and algorithmic change assessments.

Requirements

• Bachelor's degree in engineering, computer science, or statistics required.
• 5+ years of experience in regulatory affairs within medical device, digital health, or life sciences.
• Must not require employer-sponsored work authorization now or in the future.
• Technical experience with SaMD, AI/ML products, FDA guidance, and ISO 13485/14971/IEC 62304 standards.
• Proficiency with Jira, GitHub, and document control systems.
• Strong analytical and statistical skills for regulatory evaluation.

Nice to have

• Experience with international frameworks like EU MDR, Health Canada, or TGA.
• Advanced degree (MS, PhD) or RAC certification.
• Hands-on experience with post-market surveillance for LLM or AI/ML products.
• Experience using generative AI tools to enhance compliance workflows.

Culture & Benefits

• Competitive base salary with bonus and equity components.
• Comprehensive benefits package.
• Opportunity to work at the intersection of AI, data science, and healthcare.
• Equal opportunity employer committed to diversity and inclusion.