Head Of Regulatory Affairs

TL;DR

Head Of Regulatory Affairs: Leading global and domestic regulatory strategy, filings, and compliance for clinical trials and AI-driven SaMD products with an accent on FDA regulatory frameworks and healthcare AI innovation. Focus on operationalizing regulatory requirements, cross-functional coordination, and building scalable regulatory processes in a startup environment.

Location: Onsite in Palo Alto, CA, with relocation required if not local

Company

hirify.global develops a safety-focused large language model (LLM) for healthcare, aiming to improve global health outcomes through advanced AI technology.

What you will do

• Develop and execute regulatory strategies and submissions for AI-enabled SaMD products and clinical trials.
• Prepare regulatory documentation and filings, coordinating cross-functional inputs and timelines.
• Build and maintain regulatory compliance frameworks aligned with FDA and industry standards.
• Collaborate with legal, clinical, product, and engineering teams to ensure regulatory alignment and risk management.
• Lead internal regulatory training and provide clear guidance to cross-functional teams.
• Innovate regulatory processes suitable for a fast-paced startup without compromising compliance.

Requirements

• Must be located in or willing to relocate to Palo Alto, CA.
• 10-12 years of regulatory affairs experience in medical devices, pharmaceuticals, digital health, and FDA-regulated products.
• Bachelor’s degree in life sciences required; advanced degrees and RAC certification preferred.
• Strong experience with FDA regulations, submissions (INDs, NDAs, 510(k)s, etc.), and AI/ML medical technologies.
• Excellent communication skills for regulatory submissions and cross-team education.
• Ability to thrive in a dynamic startup environment with high ownership.

Nice to have

• Experience in startups or emerging-growth companies.
• Prior leadership in building regulatory frameworks and managing cross-functional initiatives.

Culture & Benefits

• Work onsite in a visionary AI healthcare startup.
• Collaborate with leading experts in healthcare and AI.
• Opportunity to impact global health through innovative technology.