MedTech Operations
10 hours ago
Barcelona
At ABCDx, we're not building "just another MedTech startup." We're building technology that can fundamentally change how stroke is diagnosed — faster, earlier, and more accurately — with real consequences for patients' lives. Science got us here. Execution will take us to patients, hospitals, and impact at scale. That's why we're looking for a Head of Operations who wants to build the operational backbone of a company moving from research excellence to commercial credibility. This is not a role where you "maintain systems." This is a role where you build them, own them, and make them work. You act as the CEO's right hand on execution, bringing structure, clarity, and follow-through across regulatory, manufacturing, finance, and commercial/legal execution. In our Holacratic, self-managed environment, authority comes from ownership, not hierarchy. You see what needs to be done — and you do it. Company Execution & Operating Rhythm You turn strategy into action and ensure the company moves in sync. • Translate board and leadership strategy into clear operational roadmaps with owners, timelines, and KPIs, • Run monthly and quarterly execution reviews across all functions, • Ensure cross-functional alignment between R&D, Regulatory, Clinical, Commercial, and Finance You make sure regulatory and quality systems are implemented, used, and audit-ready. • Own delivery and tracking of FDA (510(k), De Novo), IVDR, and AI Act workstreams, • Ensure QMS, DHF, V&V, PMS, CAPA processes are implemented — not just designed, • Coordinate internal teams and external consultants to hit regulatory timelines You build scalable, resilient operational foundations. • Own industrial readiness from prototype to scalable production, • Manage manufacturing agreements, yields, COGS, and quality control, • Implement dual-sourcing and risk-mitigation strategies across EU, UK, and US You bring financial rigor and investor-grade clarity. • Own the operating budget, cash runway monitoring, and burn control, • Implement financial dashboards linking costs, milestones, and use of proceeds, • Translate strategy into credible use-of-funds plans for bridge and Series A rounds You reduce risk and founder dependency by institutionalizing what matters. • Professionalize governance processes: board materials, reporting cadence, and decision logs, • Support shareholder agreements, ESOP clean-up, and cap table discipline, • Review, challenge, and negotiate supplier, manufacturing, and commercial contracts You ensure go-to-market ambitions are operationally achievable. • Ensure HEOR, pilot studies, and market access workstreams are executed on time, • Support U.S. and EU go-to-market preparation from an operational readiness perspective, • Your work saves lives. We're here to change how brain injuries are diagnosed — and every decision you make contributes to technology that can truly matter for patients and families., • You belong to a team, not a hierarchy. We believe in hiring for strengths and complementing weaknesses. No one is great at everything, and that's okay—we build teams that lift each other up. Expect honest feedback, open discussions, and collaboration without ego. We challenge each other's ideas because that's how we grow., • You own your decisions. No micromanagement, no clock-watching — just freedom, responsibility, and accountability for outcomes that matter. Holacracy means authority is distributed—you're responsible for driving your work forward., • You're encouraged to be bold. We experiment, learn fast, and improve constantly. Trying, failing, and iterating are part of building something meaningful., • Proven experience in MedTech / IVD / SaMD operations, • Strong execution knowledge of FDA, IVDR, ISO 13485 environments, • Financial literacy across budgets, runway, COGS, and investor expectations, • Experience preparing companies for Series A or institutional investment, • Experience reviewing, negotiating, and managing supplier and commercial contracts, • Background or strong exposure to commercial law (education or on-the-job experience), • Comfortable acting as a critical counterpart to suppliers, partners, and advisors, • See the direct impact of your work — internally and in the real world, • Work in a purpose-driven, self-managed startup with real autonomy., • Join a team that values honesty, curiosity, and collaboration over hierarchy., • Have the freedom to experiment, learn, and innovate without fear of failure., • The opportunity to build the operational foundation of a scaling MedTech startup, • Work in a beautiful office in an UNESCO world heritage site in Barcelona with one of the best rooftop views in the city, but also freedom for remote working and flexible work schedule
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