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
Deposit Operations Representative at Texas First Bank handling a range of deposit operations duties and customer service tasks. Independently performing functions such as wire transfers and fraud monitoring while ensuring excellent customer engagement.
Treasury Management Operations Specialist responsible for implementing TM services and providing customer support. Focus on technical expertise and detail with Texas First Bank's products and services.
Operations Lead managing finance, HR, compliance, and business operations for AI - powered market research startup. Building the operational foundation and systems for scaling the company.
Operations Manager responsible for outpatient laboratory services in Denver health system. Ensuring operational efficiency and compliance across multiple locations while supporting service growth.
Operations Manager at Echo NDE leading teams in inspection operations across projects and client sites. Ensuring safe, efficient, and high - quality service delivery while managing operational resources.
Senior Customer Operations Manager at Uline overseeing customer service operations across multiple branches. Focused on enhancing service quality and managing vendor relationships while reporting key performance metrics.
Customer Operations Associate managing customer operations at Forma.ai, a startup optimizing sales compensation processes. Collaborating with customers and internal teams for product and process improvement.
Quality Control Analyst implementing Eversource's QC program in gas operations. Ensuring compliance with safety and construction standards, conducting inspections, and verifying qualified personnel.
Returns Stock Processor ensuring accurate receipt and processing of stock returns for MTN's Warehouse operations. Vital role in maintaining stock integrity and compliance with returns criteria.
Analista de Operações de Tecnologia role involves managing domains, infrastructure, and systems integrations. Supports technology evolution while ensuring operational continuity in a collaborative environment.