Director of Regulatory - 2543

This is a ground-floor build opportunity for a regulatory and quality leader (Director) ready to own something meaningful. You'll be the first dedicated hire in this function — architecting the QMS, leading FDA submissions, and advising on a hardware pipeline with three devices behind it. High autonomy, direct access to leadership, and a clear path to building a team under you as the company scales.Why You'll Love It You're building the function from scratch — not inheriting someone else's system or maintaining the status quo Direct seat at the table with senior leadership and R&D — your work shapes product decisions, not just compliance checkboxes A company that moves fast, values results, and gives you the runway to do your best work without layers of bureaucracyIdeal Candidate Class II medical device experience with hands-on 510(k) submissions — background in cardiac monitoring, cardiology devices, or digital health strongly preferred Has built or significantly scaled a QMS independently — comfortable owning both regulatory and quality without a team around them Builder mentality over maintainer — thrives in a lean, entrepreneurial environment and knows how to prioritize what actually matters