Dr Toni Day is a regulatory and quality management professional with over 20 years’ experience in the

development of strategies for complex and novel regulatory submissions for medical devices,

software as a medical device (SaMD), biologicals and in vitro diagnostics (IVD) in many different

territories, medical device design and development and market approval. With a career focussed on

fast-paced, innovative environments and solving challenging regulatory conundrums.

Extensive working knowledge of initiating, leading and managing medical device clinical trials in

accordance with ISO 14155, 21 CFR 50, 56 and 812 and GCP. Including completion of protocols, and

statistical sampling plans, IRAS documentation, IDE Pre-submissions and submissions with FDA.

Managing clinical trials including onsite monitoring of site master files.

Most recently to lead and develop the global regulatory strategy to bring the novel normothermic

machine perfusion devices, to market. In doing this, collaborating with cross-functional teams to

ensure compliance and drive regulatory excellence across the product lifecycle. With new venture

research projects for both Biological, therapeutic and combination devices and devices including

software, developing the regulatory strategies. Worked closely with the OrganOx clinical specialists

team, shadowing surgery and customer visits and aligning all stakeholders.

The Royal Academy of Engineering (RAEng) MacRobert Award finalist in 2019 and 2025 for the

OrganOx metra.

Working with the relevant business functions to identify regulatory requirements for determination

of regulatory strategies. Representing companies in regulatory matters to influence outcomes and

establish strong and valuable partnerships including communicating with regulatory and

governmental agencies. Close collaboration with the clinical and surgical teams to ensure that

patient safety is always maintained. Leading complex negotiations with regulatory authorities.

Managing post market surveillance activities, complaints, field safety corrective actions, product

recalls and medical device reporting of adverse incidents and evaluate to determine any regulatory

actions required.

Development and management of Quality Management Systems to MDSAP, ISO 13485 and CFR 820,

including manufacturing quality and operational quality improvements. From inception to approval.

Qualified Person Responsible for Regulatory Compliance (PRRC) in accordance with MDR

2017/745.