Staff Regulatory Affairs Associate (AI)

TL;DR

Staff Regulatory Affairs Associate (AI): Developing and driving regulatory strategies for Software as a Medical Device (SaMD) and AI-enabled wearable technologies with an accent on FDA and EU MDR compliance. Focus on evaluating novel technologies, defining regulatory pathways, and providing strategic guidance to cross-functional product and engineering teams.

Location: Must be based in or be able to relocate to Boston, MA

Salary: $170,000 - $220,000

Company

hirify.global is a wearable health technology company focused on continuous physiological monitoring and advanced analytics to improve performance and long-term health.

What you will do

• Develop and drive regulatory strategies for SaMD, AI/ML-enabled products, and digital health solutions.
• Serve as the primary regulatory advisor to cross-functional teams throughout the product development lifecycle.
• Partner with Product, Engineering, and AI/ML teams to evaluate regulatory implications of new features and algorithms.
• Support regulatory interactions with FDA reviewers, notified bodies, and other authorities.
• Provide strategic leadership for FDA and EU submissions, including Q-Submissions, 510(k)s, and De Novo requests.
• Monitor and interpret evolving requirements related to digital health, AI/ML, and software lifecycle processes.

Requirements

• 8+ years of Regulatory Affairs experience within the medical device industry.
• Bachelor’s degree in Regulatory Affairs, Engineering, Computer Science, or related field.
• Demonstrated experience developing regulatory strategies for SaMD, digital health, or AI/ML-enabled medical technologies.
• Strong understanding of FDA medical device regulations, pathways, and submission processes.
• Working knowledge of international regulations, particularly FDA and EU MDR frameworks.
• Must be based in or willing to relocate to the Boston, MA office.

Culture & Benefits

• Competitive base salary and meaningful equity package.
• Opportunity to work at the intersection of product innovation, AI, and regulatory affairs.
• Commitment to a diverse and inclusive work environment.
• Comprehensive benefits package designed to support long-term growth and success.