Chief Operating Officer - MedTech in England

Our client is a pioneering, early-commercial-stage medical device company at the forefront of their field of expertise. Developed as a spinout from a leading UK university and NHS Foundation Trust, the company has built a proprietary device. Based on a scientifically validated methodology with decades of underpinning research, the platform is unique and a game changer, in transforming what is currently a critical four-to-six-hour window into a clinically manageable, logistically flexible timeline. Following a successful funding round and significant team expansion, the company is now establishing its operational foundations for clinical deployment and commercial scale. It has offices and a team in the UK and is building rapidly across regulatory affairs, quality assurance, software engineering, and commercial readiness. However, the commercial focus of the business is the US. The appointment of a COO is the next critical step in this journey.

The Chief Operating Officer will be the operational architect of the company — building and leading the end-to-end operational infrastructure that will take the device through UKCA/CE certification, first-in-human clinical deployment, NHS and international commercialisation, and manufacturing scale-up. This is a broad, highly consequential leadership role spanning regulatory affairs, quality management systems, manufacturing operations, supply chain, clinical deployment, and team building. The COO will work in close partnership with the CEO, CFO, CSO, and CIO — forming the senior leadership team that will guide the company through its most pivotal phase of growth.

The ideal candidate is an experienced MedTech operations leader who has navigated the regulatory and operational complexities of bringing a novel medical device to market — someone with the strategic vision to architect a world-class operational function and the hands-on credibility to build it from the ground up.

• Regulatory Affairs & Device Certification: Lead and own the company's UKCA and CE regulatory pathway — developing and executing the regulatory strategy to achieve market authorisation for the device in the UK and EU, and subsequently the FDA 510(k)/De Novo pathway for US market entry. Build and manage the regulatory affairs function — including technical file preparation, notified body liaison, MHRA interactions, clinical evidence strategy, and post-market surveillance frameworks. Oversee the preparation and submission of all regulatory documentation — ensuring the device's design history file, risk management file, and clinical evaluation reports meet the requirements of UKCA, EU MDR 2017/745, and equivalent international frameworks. Develop and maintain regulatory intelligence — monitoring evolving device regulations, NHS procurement policy, and international market access.
• Quality Management Systems: Design, implement and maintain an ISO 13485-compliant Quality Management System — establishing the QMS infrastructure from the ground up, including SOPs, CAPA processes, supplier qualification, and document control. Lead the company through ISO 13485 certification and any subsequent quality audits — acting as the Quality Management Representative and primary interface with certification bodies and regulatory inspectors. Embed a quality-first culture across the organisation — ensuring every function, from engineering to clinical operations, understands and operates within the quality framework required of a regulated medical device company.
• Manufacturing, Supply Chain & Device Operations: Own and develop the end-to-end manufacturing and supply chain strategy for the device — from prototype through low-volume clinical supply to scalable commercial manufacturing, whether in-house, through contract manufacturers, or a hybrid model. Identify, qualify and manage contract manufacturing partners — overseeing supplier qualification, technical transfers, manufacturing agreements, and ongoing supply chain risk management. Lead operational readiness for first-in-human clinical deployment — coordinating the logistics, training, device servicing, and field support infrastructure required to deploy the device safely in clinical settings. Develop the device servicing, maintenance and field operations model — including training protocols for clinical staff, device monitoring capabilities, and post-deployment technical support.
• Clinical Operations & NHS / Healthcare System Engagement: Lead operational engagement with NHS centres, and international healthcare systems — building the clinical deployment, training and support infrastructure needed for successful real-world adoption. Develop and oversee clinical deployment protocols — including device installation, staff training, in-use monitoring, adverse event reporting, and post-market data collection in partnership with clinical leads and the CSO. Manage relationships with key NHS partners, NHSBT, and networks — ensuring the company's operational capabilities meet the safety, quality, and logistical expectations of clinical partners.
• Team Building & Operational Leadership: Build and lead the company's operational, regulatory, and quality teams — recruiting, developing, and managing a growing multidisciplinary team across engineering, QA/RA, manufacturing, and clinical operations. Work in close partnership with the CEO, CFO, CSO and CIO — contributing to strategic planning, board reporting, investor due diligence, and the broader leadership of a high-growth MedTech company. Develop and own operational KPIs, project timelines, milestone reporting, and risk management frameworks — providing the CEO and Board with clear, reliable visibility of operational performance and regulatory progress.

• Experience: Significant operational leadership experience in a medical device or MedTech company — with specific, demonstrable experience navigating the UKCA, CE marking (EU MDR 2017/745), or equivalent regulatory pathway for a Class IIa or Class IIb active medical device. Hands-on experience building or leading an ISO 13485 QMS — including certification, internal audit, CAPA management, and regulatory inspection readiness. Experience of medical device manufacturing and supply chain management — including CMO selection and qualification, technical transfers, and scaling from clinical supply to commercial volumes. Experience working within or alongside NHS clinical settings. A track record of building operational teams and functions from an early stage in a scaling MedTech or life sciences business.
• Technical Knowledge: Deep understanding of the EU MDR 2017/745 and UKCA device frameworks — including technical documentation requirements, clinical evidence standards, PMS obligations. Strong knowledge of ISO 13485, ISO 14971 (risk management), IEC 62304 (medical device software) and relevant harmonised standards applicable to active, connected medical devices. Familiarity with device software validation, cybersecurity considerations, and the regulatory implications of software as a medical device (SaMD) is advantageous.