Mirrai Careers

Senior Regulatory Affairs Program Manager

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San Francisco-HQ Remote Full-time$168k–$225k / year Posted 8d ago
Market rate. This role pays around the $178k median for similar USD roles (289 comparable postings in our corpus).
In this role, you will be responsible for the hands-on authorship and management of regulatory submissions (510(k), De Novo, Pre-Subs) for our cutting-edge AI products. You will partner closely with Product, Clinical, and Engineering teams to interpret the evolving FDA framework for AI/ML, helping us navigate complex pathways like Predetermined Change Control Plans (PCCP). You will also own the internal regulatory functions that support our Quality Management System, ensuring our rapid innovation remains compliant. WHAT YOU’LL ACCOMPLISH * Submission Leadership (AI/ML SaMD): Lead the…

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