Job Description
We're seeking a highly experienced Regulatory Consultant to lead the FDA clearance strategy for a proprietary AI-based medical imaging solution. The ideal candidate has a proven track record of navigating the Software as a Medical Device (SaMD) pathway, specifically for AI/ML-enabled technologies.
You will work closely with our engineering and product teams to transition an existing AI solution from a functional prototype to a production-ready, FDA-cleared medical asset.
Key Responsibilities
Regulatory Strategy: Define and execute the optimal FDA submission pathway (e.g., 510(k), De Novo) for an AI-SaMD product.
Documentation & QMS: Lead the development of the Technical Documentation File, including Software Requirement Specifications (SRS), Risk Management (ISO 14971), and Human Factors Engineering.
Technical Oversight: Provide guidance on architectural refactoring, security hardening, and "Algorithm Change Protocol" to ensure compliance with FDA’s latest AI/ML guidance.
Clinical Validation Support: Advise on clinical performance testing and validation protocols required to demonstrate safety and efficacy.
FDA Liaison: Act as the primary point of contact for Pre-Submission (Pre-Sub) meetings and formal responses to FDA inquiries.
Required Qualifications
Direct FDA Experience: Minimum 5+ years of experience in regulatory affairs, with at least two successful FDA clearances for AI-enabled SaMD.
Technical Fluency: Deep understanding of AI/ML lifecycles, including data bias mitigation, model retraining protocols, and "black box" transparency requirements.
Standards Expertise: Mastery of IEC 62304 (Software Lifecycle), ISO 13485 (QMS), and UL 2900 (Cybersecurity).
Communication: Ability to translate complex regulatory requirements into actionable technical tasks for software engineers.
Preferred Skills
Experience with medical imaging platforms and DICOM standards.
Previous collaboration with external partners on platform orchestration and interface implementation.
Background in Cloud-based (SaaS) medical deployment.
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