Meet the Team

Jessica is the Head of Regulatory Affairs at LFH Regulatory. After achieving a BSc (Hons) in Biology at Queen Mary University of London, she completed an Internship in Project Management at a global pharmaceutical company, which is where her interest in medical devices and regulatory affairs started. Since then she has worked on a large variety of devices and worked on global registrations for Class I SaMD to Class III Implants, in small start-up organisations to large global companies.

The last few years she has specialised in regulatory strategy for software and digital health tools in global markets and the many ways in which software can be leveraged in healthcare; from data collection tools in drug development to their use in disease management and beyond.

Yupei is the Clinical and Regulatory Consultant at LFH Regulatory. She is an expert in Performance Evaluation and Post Market Surveillance documentation of Molecular Diagnostic and Companion Diagnostic IVDs.

After her PhD in Respiratory Medicine at the University of Hull, Yupei worked as Post-doc Research Fellow at Hull York Medical School (Castle Hill Hospital, Hull). Yupei has profound experiences in managing NHS funded oncology trials, which include drafting study protocol, preparing the Ethics application, data analysis & interpretation, and manuscript preparation for journal submission.

She has over 8 years’ extensive industry experience working with varying sized organisations and with a diverse range of in vitro diagnostics products. Yupei has a breadth of knowledge that includes Regulatory, Quality, Design & Development, and Medical Writing. Additionally, she is also experienced in managing the investigator let studies (ILS) in IVD products.

Alexander is a Quality Assurance and Regulatory Affairs Consultant at LFH Regulatory. He obtained a BSc (Hons) in Biomedical Sciences from Durham University before completing a MSc specialising in Haematology at the University of Westminster. Alexander commenced his professional career in 2020, supporting the transfer of numerous pharmaceutical Marketing Authorisations at the MHRA. From here, Alexander moved to the medical devices sector and has worked with several leading manufacturers on a range of devices, spanning from class I to class IIb.

Notably, Alexander has utilised his keen analytical skills to navigate some key complex regulatory changes, including Brexit and Swixit, to ensure seamless market access and sustained compliance. Further, his responsibilities have included the development and maintenance of device technical files, performing regulatory impact assessments and co-ordinating regulatory responses across all aspects of change management.

With a strong focus on continued learning, Alexander is dedicated to applying his scientific background in support of the safe and timely introduction of innovative medical technologies that enhance patient care.

Amrita is the Quality Assurance and Regulatory Affairs Consultant at LFH Regulatory. She earned her BSc (Hons) in Biomedical Science from the University of Birmingham in 2019 and embarked on her professional journey shortly thereafter. Initially, she worked in Medical Information and Product Technical Complaints for Pharmaceuticals and Combination Products. Later, she transitioned to Regulatory Affairs, gaining expertise across all Classes of Medical Devices.

Amrita’s extensive background includes creating and developing technical files from scratch, devising and executing regulatory pathways and strategies. She has streamlined processes for generating and submitting new registration packs, renewal packs, and change notifications for medical devices on a global scale. Additionally, she has authored and implemented SOPs and Work Instructions to enhance Quality Management System (QMS) processes. As part of her role, she leads Regulatory Intelligence efforts, overseeing impact assessments and global regulatory surveillance.

Driven by a passion for patient safety, Amrita remains committed to contributing to the field of medical devices. She continues to learn and grow within the regulatory landscape.