Lab Operations Specialist supporting daily quality control activities by managing laboratory functions. Ensuring smooth operations and adherence to regulatory requirements in a pharmaceutical context.
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
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
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