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.
