lensai.tech
FDA Medical AI Consultant – SaMD, Risk, Clinical Validation
lensai.tech - New York, New York, United States
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Overview
FDA Medical AI Consultant – SaMD, Risk, Clinical Validation
LensAI integrates compliance into AI development workflows by automating traceability, risk management, and evidence generation for regulatory standards such as FDA, EU AI Act, ISO 42001, and GMLP. Our platform transforms AI development processes into compliant, audit-ready pipelines. We are seeking
experienced consultants
to collaborate on a
per-project basis , providing specialized guidance in areas such as: Clinical validation strategy (e.g., STARD-AI, CLAIM, SPIRIT-AI) Risk management and post-market safety planning (ISO 14971, TPLC) Qualifications: Proven experience with
regulatory filings
and
clinical validation
for medical AI Ability to serve as a
specialist for scoped projects
(not a full-time role) Comfort working with early-stage teams developing novel AI technologies This role does
not offer fixed compensation or full-time employment . We provide
project-based consulting fees , determined by your expertise and project fit. Our goal is to build a strong network of advisors and fractional contributors, and we look forward to working with you
when the right opportunity arises . Additional Details
Seniority level:
Mid-Senior level Employment type:
Contract Job function:
Engineering and Information Technology Industries:
Technology, Information and Internet
#J-18808-Ljbffr
LensAI integrates compliance into AI development workflows by automating traceability, risk management, and evidence generation for regulatory standards such as FDA, EU AI Act, ISO 42001, and GMLP. Our platform transforms AI development processes into compliant, audit-ready pipelines. We are seeking
experienced consultants
to collaborate on a
per-project basis , providing specialized guidance in areas such as: Clinical validation strategy (e.g., STARD-AI, CLAIM, SPIRIT-AI) Risk management and post-market safety planning (ISO 14971, TPLC) Qualifications: Proven experience with
regulatory filings
and
clinical validation
for medical AI Ability to serve as a
specialist for scoped projects
(not a full-time role) Comfort working with early-stage teams developing novel AI technologies This role does
not offer fixed compensation or full-time employment . We provide
project-based consulting fees , determined by your expertise and project fit. Our goal is to build a strong network of advisors and fractional contributors, and we look forward to working with you
when the right opportunity arises . Additional Details
Seniority level:
Mid-Senior level Employment type:
Contract Job function:
Engineering and Information Technology Industries:
Technology, Information and Internet
#J-18808-Ljbffr