Toni Day
Expert in Residence at University of Oxford | Kidlington, England, United Kingdom
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Toni Day serves as the Global Director of Quality and Regulatory Affairs at OrganOx Ltd, where she leverages her extensive expertise in medical device product design and development to ensure compliance across multiple international markets. With a robust background in navigating the complexities of regulatory frameworks, Toni has successfully established compliance protocols in territories including the UK, Europe, the USA, Australia, Saudi Arabia, Singapore, Canada, Brazil, and beyond. Her proficiency in critical guidelines such as ISO 13485, MDSAP, MDR, and 21 CFR 820 positions her as a key player in the development of Class II and Class III medical devices.
In her current role, Toni is responsible for the meticulous preparation and management of product Technical Files and Design Dossiers, ensuring that all documentation meets the stringent requirements for product testing, including ISTA, IP, IEC 60601 (including the 4th Edition), ISO 10993, sterility, and shelf life assessments. Her leadership extends to overseeing CE marking processes, conducting internal and external audits, and facilitating submissions to regulatory bodies such as the FDA, including 513(g), Pre-Sub, IDE, PMA, and 510(k) applications.
Toni's commitment to Good Manufacturing Practice (GMP) and her deep understanding of the medical device landscape empower her to drive innovative solutions while maintaining the highest standards of quality and safety. Her collaborative approach fosters cross-functional teamwork, ensuring that product development aligns seamlessly with regulatory expectations. With a passion for advancing healthcare technology, Toni Day continues to make significant contributions to the field, positioning OrganOx Ltd at the forefront of medical device innovation.
Expert in Residence at University of Oxford in January 2019 to Present
Founder and Director at Regulatory Insights in April 2025 to Present
Committee Member at BSI in April 2025 to Present
Senior Director Regulatory Affairs and interim VP global Quality at OrganOx in July 2024 to April 2025
Global Director of Quality and Regulatory Affairs at OrganOx in April 2011 to April 2025
Regulatory Affairs/Quality Management at Hawtin Scientific Consultancy in April 2011 to April 2011
Consultant at Hawtin Scientific Consultancy in February 2010 to April 2011
Head of Project Management at Oxford BioTherapeutics in January 2011 to April 2011
Director, Product Development at Oxford Immunotec Ltd in February 2003 to January 2010
Senior Scientist/Project Leader at Synaptica in January 2001 to February 2002
Postdoctoral scientist at University of Oxford in January 2001 to September 2001
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medical device validation
LDT
Premarket Approval (PMA)
Medical Device Regulation (MDR)
MDRs
Ivdr
IVDD
CE marking
Strategy
Marketing Strategy
UKCA
TGA
Health Canada
Data Analysis
U.S. Food and Drug Administration (FDA)
Good Manufacturing Practice (GMP)
Project Management
Medical Devices
Product Development
FDA
ISO 13485
Assay Development
In Vitro
Biotechnology
Lifesciences
Clinical Trials
R&D
Regulatory Affairs
Clinical Development
GMP
Validation
Molecular Biology
Clinical Research
Immunoassays
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Discover more about University of OxfordWhat is Toni Day email address?
Email Toni Day at [email protected]. This email is the most updated Toni Day email found in 2026.
How to contact Toni Day?
To contact Toni Day send an email to [email protected]. (updated on October 31, 2024)
What company does Toni Day work for?
Toni Day works for University of Oxford
What is Toni Day's role at University of Oxford?
Toni Day is Expert in Residence
What is Toni Day's Phone Number?
Toni Day's phone +44 ** **** *337
Toni Day Email Addresses
Toni Day Phone Numbers
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