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US Legal Counsel

Caristo Diagnostics - Remote - Remote - posted 2026-10-16

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Caristo Diagnostics, a rapidly growing medical-device company founded as a spin-out from the University of Oxford in 2018, is seeking a commercially minded US attorney to join as the company's first legal hire in the United States. The company has developed CaRi-Heart®, the first and only FDA-approved coronary artery inflammation diagnostic medical device (approved July 2026), and also offers an FDA-approved coronary artery plaque diagnostic device. Caristo was named a 2026 Technology Pioneer by the World Economic Forum. Reporting to the CEO, you will work remotely with regular in-person meetings, supporting the expansion of US operations and building out the US legal function from the ground up. You will work closely with the leadership team and UK legal colleagues, providing practical advice across commercial, compliance, and employment matters. Key responsibilities include: **Commercial Contracts:** Lead drafting, review, and negotiation of US commercial agreements including customer contracts with hospitals, diagnostic imaging centers, cardiology practices, and longevity clinics; pharmaceutical company agreements; master services agreements; supplier license agreements; honorarium and consultancy agreements with key opinion leaders; clinical study and research collaboration agreements; and confidentiality agreements. Develop and maintain contract templates, playbooks, policies, and approval processes in partnership with Sales Operations. Build a scalable contracting process that accelerates customer onboarding while maintaining proportionate risk controls. **US Compliance & Risk:** Lead US legal and regulatory compliance in partnership with Regulatory, HR, and Quality functions. Monitor developments in US law and regulation, particularly those affecting software, AI, and medical devices, translating them into practical business guidance. Ensure significant legal and regulatory changes are reflected in strategic plans. Draft and maintain governance and compliance policies addressing Sunshine Act and HIPAA requirements. Deliver practical legal training and promote awareness of company policies and compliance obligations. Partner with UK Legal to develop and implement a Code of Conduct covering anti-kickback, bribery and corruption, sanctions, competition law, fraud, whistleblowing, conflicts of interest, and modern slavery. **US Employment Support:** Advise HR on US employment matters and disputes. Support compliance with employment laws and regulatory requirements. Help foster a collaborative, positive, and fair culture across UK and US locations. **Disputes:** Advise on disputes, investigations, and pre-litigation matters, coordinating external counsel where appropriate. The ideal candidate is a self-starter motivated by working in an innovative medtech start-up with a strong collaborative culture, helping to build a global business with material impact on health and wellbeing. You should be collaborative, building trusted relationships across teams; commercial, understanding business objectives with excellent drafting and negotiation skills; pragmatic, identifying practical solutions; a clear communicator who explains complex legal issues concisely; accountable, taking ownership through to completion; and adaptable and organized, working independently in a fast-paced environment. **Requirements:** - Juris Doctor (JD) from an accredited US law school - Active membership in good standing with at least one US state bar - At least six years' post-qualification legal experience gained in a reputable law firm, in-house legal team, or combination of both - Strong expertise in commercial contracting, US privacy law, and data-security requirements **Desirable Experience:** - Experience in medical devices, healthcare technology, and/or software - Experience supporting a high-growth or scaling business - Experience working across multiple US states or with international teams - Familiarity with contract lifecycle management systems and legal-operations tools - Experience selecting and managing external legal and professional advisers

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