Hybrid MedTech Operations

Posted 16 minutes ago

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About the role

  • Head of Operations at ABCDx developing the operational foundation for innovative stroke diagnosis technology. Overseeing all functions from regulatory to commercial execution in a self-managed startup environment.

Responsibilities

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

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

Job title

MedTech Operations

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

No Education Requirement

Location requirements

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