Meet the Team

Laura Friedl-Hirst

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 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.

Jessica Hambidge

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.

Helen George

Helen is the Business Manager at LFH Regulatory who brings a wealth of experience and valuable insights from the field of medical devices. Like many, she had not decided on Regulatory Affairs as her chosen career, in fact, she was introduced to it when temping at a medical device start-up whilst finishing her MSc in Occupational Psychology in 2012.

Helen’s early contributions led to the success of a clinical trial, extending the claims on a new CE-marked medical device but more recently, her experience spans consultancy, Regulatory Affairs and Quality Management.

She currently is supporting the Managing Director in all areas of the business to develop LFH Regulatory and grow the company’s portfolio.

Ellie Shackleton

Ellie is the Clinical and Regulatory Consultant at LFH Regulatory, since graduating from the University of Hull in Biomedical Science (hons) she has developed a broad range of medical device, and in-vitro diagnostic device experience. She has experience in MedTech product development where she has created, developed, and brought many different medical devices to the market.

Working in both small and large organisations, she has developed her experience in the clinical and regulatory landscape, where she has helped to support MDD, EU MDR, and IVDR submissions.

Ellie loves working as a Clinical and Regulatory Consultant as she has exposure to many parts of the industry, she gets to work with lots of like-minded, and passionate people, and together they navigate the ever-changing regulatory landscape to bring devices to the market.

Dr Yupei Xiao

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.

Josephine Shonaike

Josephine is a Medical Writer at LFH Regulatory. After gaining a BSc Biomedical science degree she has gone on to work in various roles within pharmacovigilance, public health surveillance and regulatory affairs. She began her career in 2021 as a medical writer at a Biotechnology company, where she gained experience in writing technical documentation including STED files and Performance Evaluation documentation for a portfolio of clinical microbiology devices. She has developed her knowledge of IVD regulations and requirements.

She has since developed an interest in the medical device industry and its value to the advancement of patient healthcare. She is continuing to expand her technical writing skills and IVD knowledge by managing, writing and reviewing Performance Evaluation documentation for multiple projects across a portfolio of varying IVDs, as well as providing valuable expertise.

Hayley Barwick

Hayley is the Senior Quality Assurance and Regulatory Affairs Consultant at LFH Regulatory. Her role is supporting clients with any quality and regulatory challenges they may face.

Hayley’s experience comes from working in the medical device industry for the past 13 years. After graduating in Business Management in 2015, her career focused strongly in the direction of quality and regulatory, where she became the Quality and Compliance Manager for a surgical instrument manufacturer for 6 years. Hayley’s experience is vast and covers many areas in quality and regulatory including but not limited to, QMS implementation, design and development, post-market surveillance, risk management, biocompatibility and sterilisation requirements.

Hayley has a passion for delivering great customer service and endeavours to ensure that our clients receive excellent service and the support they need.

Lyndon Boyer

Lyndon is the Quality Assurance and Regulatory Affairs Consultant at LFH Regulatory.  He attended the University of Manchester where he gained a BSc (Hons) in Biomedical Sciences.  Over the last 6 years he has immersed himself in the med tech sector, specialising in the quality and regulatory field.

His extensive background covers a wide array of medical devices, ranging from class I to class IIb, encompassing both sterile and reusable devices for non-active IV and enteral feeding purposes. Notably, his recent role involved collaborating with a prominent contract packaging company, where he assisted numerous medical device manufacturers in managing their diverse portfolios.

Lyndon’s areas of expertise span technical file creation and remediation, clinical evaluation documentation, risk management according to ISO 14971 standards, biological evaluation, and post-market documentation.

His ultimate goal is to contribute to the introduction of new and innovative medical devices that can enhance public health and well-being.