Digital Health FDA Consultant (SaMD - AI / Generative AI / LLMs)

Job Title : Digital Health FDA Consultant (SaMD - AI / Generative AI / LLMs)

Location : Remote (USA or India)

Engagement : Contract (Part-Time)

About the Role

We are seeking an experienced Digital Health FDA Consultant with deep expertise in Software as a Medical Device (SaMD) and hands-on experience guiding AI-driven products through the FDA clearance process. The ideal consultant will have strong knowledge of Generative AI, Large Language Models (LLMs), and AI-enabled disease diagnosis workflows, and can advise our team on regulatory, compliance, safety, and validation requirements.

This role is ideal for someone who has supported early-stage health tech or digital health companies in successfully navigating SaMD regulatory pathways.

Key Responsibilities

• Provide end-to-end regulatory guidance for FDA SaMD submissions (510(k), De Novo, Pre-Sub, etc.)
• Develop and review documentation including :

SaMD Risk Analysis (ISO 14971)

Continuous learning algorithms

FDA's AI / ML SaMD Action Plan

Product requirements

Required Qualifications

IMDRF SaMD Framework

Preferred Qualifications