Regulatory & Quality Strategy Lead (SaMD & AI)

Regulatory & Quality Strategy Lead (SaMD & AI)

We are pioneering the future of AI-powered healthcare software.

As our Director of RA/QA you’ll steer the development and execution of our regulatory, quality, and clinical operations strategies.

We are looking for a strategic Regulatory Affairs leader to build and execute our regulatory and quality roadmap from the ground up. The ideal candidate has a proven track record of taking complex, multidisciplinary AI-driven SaMD products through successful FDA clearance.

Requirements

• Proven FDA Success: At least [X] years of experience in Regulatory Affairs for SaMD, with a documented track record of successful 510(k) or De Novo submissions.
• Regulatory Strategy: Experience building regulatory and quality strategies for multidisciplinary products from PoC to commercialization, including "claims" framing to optimize classification.
• Standards Expertise: Deep mastery of IEC 62304, ISO 13485, and ISO 14971.
• AI/ML Specialization: Practical experience with FDA’s AI/ML-based software guidance, including the development of PCCPs (Predetermined Change Control Plans) and data lifecycle management.
• Cybersecurity & V&V: Expertise in software verification and validation (V&V) and managing cybersecurity requirements (including SBOMS and vulnerability assessments).
• Direct Agency Interaction: Extensive experience leading Pre-Submission meetings and direct communications with the FDA/Notified Bodies.
• Proven experience in preparing and submitting FDA 510(k) applications, including regulatory documentation, communication with regulatory authorities, and supporting product approvals
• Outstanding written and verbal communication skills in English

"Bottom Line" Must-Haves:

"Proven lead with at least 5 years in SaMD regulation, having successfully steered at least one AI-based multidisciplinary product through a full FDA submission cycle. Mastery of IEC 62304 and strategic experience with PCCP and cybersecurity is essential.":

• Build and evolve an ISO 13485-compliant Quality Management System designed for digital health innovation
• Oversee and mature our ISO 27001 Information Security Management System and ensure regulatory-grade cybersecurity practices
• Own U.S. and EU regulatory submissions (FDA, CE, IVDR) for software-based medical devices, with a focus on AI/ML considerations
• Ensure privacy and safety requirements (GDPR, HIPAA) are embedded throughout product development
• Lead audits and inspections with regulatory bodies and notified entities