Meet the Team

Laura is the Managing Director & Principal Consultant at LFH Regulatory, the organisation she founded in June 2019 and one that has grown vastly since it was established. Her vision was to create a consultancy and a team of consultants that have a pragmatic approach for navigating companies to their end goals. She is as passionate then as she is now about creating a culture that is open, approachable, and flexible; she also promotes a great work-life balance.

After gaining a BSc (hons) in Medical Biology at The University of Huddersfield, she completed a placement year at DePuy and was introduced to the world of regulatory affairs. Since then, she has gained over 12 years’ extensive industry experience working with varying sized organisations and with a diverse range of medical device and in vitro diagnostics. Laura has a breadth of knowledge and expertise that spans over regulatory, quality, clinical and design & development.

As she continues to grow the consultancy, she is excited to see how far it will go.

Zara is Head of Regulatory Affairs at LFH Regulatory. She attended the University of Leicester where she gained a BSc (Hons) in Biological Sciences.

Zara started her career in 2015 working in R&D for IVDs, before moving over to Quality and Regulatory. Since then, Zara moved over to working with medical devices, specifically sterile devices, SaMD and AIaMDs.

Her extensive background covers full creation, implementation and maintenance of ISO 13485 compliant QMS, validation and verification activities, conducting Internal audits, managing notified body audits, creation and maintenance of technical documentation as well as Risk Management.

Zara’s experience also includes developing and executing regulatory strategy plans, monitoring the regulatory landscape.

She aims to continue growing in the regulatory landscape in the med tech sector and contribute to innovation which can ultimately benefit patient health.

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.

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.

With a strong background in business administration and quality management, Lucy brings a wealth of experience in ensuring smooth operations and process improvement. Throughout her career, she has consistently demonstrated an exceptional ability to manage complex data, streamline processes, and drive efficiency across various functions. 

Previously, Lucy worked within the quality department of a custom implant company, where she gained in-depth experience in CAPA (Corrective and Preventive Actions), QMS (Quality Management Systems), training, and auditing. This experience has equipped her with a deep understanding of regulatory compliance and the critical role that quality control plays in the medical industry. 

As Business Administrator, Lucy applies her organisational expertise and attention to detail to support the company’s goals and ensure that operations run smoothly. With a passion for continuous improvement and an unwavering commitment to excellence, Lucy is dedicated to helping the team achieve operational success and deliver results.