MedTech Operations

Join a Mission-Driven Team Where Execution Saves Lives 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.Your Mission 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.How You'll Make a Difference Company Execution & Operating RhythmYou turn strategy into action and ensure the company moves in sync.Translate board and leadership strategy into clear operational roadmaps with owners, timelines, and KPIsRun monthly and quarterly execution reviews across all functionsEnsure cross-functional alignment between R&D, Regulatory, Clinical, Commercial, and FinanceImplement a single source of truth for milestones, risks, and dependenciesRegulatory & Quality Operations (Execution, Not RA Leadership)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 workstreamsEnsure QMS, DHF, V&V, PMS, CAPA processes are implemented — not just designedCoordinate internal teams and external consultants to hit regulatory timelinesPrepare the organization for FDA inspections, Notified Body audits, and diligenceManufacturing & Supply ChainYou build scalable, resilient operational foundations.Own industrial readiness from prototype to scalable productionManage manufacturing agreements, yields, COGS, and quality controlImplement dual-sourcing and risk-mitigation strategies across EU, UK, and USEnsure supply chain readiness aligns with regulatory submissions and pilot timelinesFinancial Discipline & Series A ReadinessYou bring financial rigor and investor-grade clarity.Own the operating budget, cash runway monitoring, and burn controlImplement financial dashboards linking costs, milestones, and use of proceedsTranslate strategy into credible use-of-funds plans for bridge and Series A roundsPrepare the company operationally for investor and partner diligenceGovernance, Legal & Internal StructureYou reduce risk and founder dependency by institutionalizing what matters.Professionalize governance processes: board materials, reporting cadence, and decision logsSupport shareholder agreements, ESOP clean-up, and cap table disciplineReview, challenge, and negotiate supplier, manufacturing, and commercial contractsManage and coordinate external legal counsel, ensuring advice translates into executionCommercial & Market Access Enablement (Operational Lens)You ensure go-to-market ambitions are operationally achievable.Ensure HEOR, pilot studies, and market access workstreams are executed on timeSupport U.S. and EU go-to-market preparation from an operational readiness perspectiveCoordinate pilots (EMS, ED, hospitals) with regulatory, manufacturing, and contractual constraintsYou will not be expected to solve everything at once. The role is about sequencing, prioritisation, and making trade-offs, deciding what must move now, what can wait, and what should not be done.What It's Like to Work at ABCDx 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.You can be yourself. No politics, no masks. Just real people, real conversations, and a shared drive to build something we're proud of. We value self-awareness. If you can talk about your strengths and weaknesses honestly, you'll fit right in.RequirementsProven experience in MedTech / IVD / SaMD operationsStrong execution knowledge of FDA, IVDR, ISO 13485 environmentsFinancial literacy across budgets, runway, COGS, and investor expectationsExperience preparing companies for Series A or institutional investmentExperience reviewing, negotiating, and managing supplier and commercial contractsBackground or strong exposure to commercial law (education or on-the-job experience)Comfortable acting as a critical counterpart to suppliers, partners, and advisorsA hands-on builder mindset — pragmatic, structured, and outcome-drivenBenefitsSee the direct impact of your work — internally and in the real worldWork 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 startupWork 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