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MedTech Operations

hace 3 semanas

Barcelona, Barcelona, España ABCDx SA A tiempo completo

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 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
  • Implement a single source of truth for milestones, risks, and dependencies

Regulatory & 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 workstreams
  • Ensure QMS, DHF, V&V, PMS, CAPA processes are implemented — not just designed
  • Coordinate internal teams and external consultants to hit regulatory timelines
  • Prepare the organization for FDA inspections, Notified Body audits, and diligence

Manufacturing & Supply Chain
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
  • Ensure supply chain readiness aligns with regulatory submissions and pilot timelines

Financial Discipline & Series A Readiness
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
  • Prepare the company operationally for investor and partner diligence

Governance, Legal & Internal Structure
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
  • Manage and coordinate external legal counsel, ensuring advice translates into execution

Commercial & 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 time
  • Support U.S. and EU go-to-market preparation from an operational readiness perspective
  • Coordinate pilots (EMS, ED, hospitals) with regulatory, manufacturing, and contractual constraints

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

Requirements

  • 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
  • A hands-on builder mindset — pragmatic, structured, and outcome-driven

Benefits

  • 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