Sarah Welsh has over five years of experience and expertise in regulatory affairs consulting and industry. She supports the development of regulatory submissions such as Q-submissions, 510(k)s, De Novo, Breakthroughs, and PMAs for organizations seeking FDA clearance/approval. Additionally, Welsh helps manufacturers develop regulatory strategies, product landscape analyses, recommendations for pre-clinical testing, and clinical data collection. She is an accomplished regulatory technical writer and has experience in development and implementation of regulatory strategy and regulatory submissions in therapeutic areas including spine, orthopedics, wound care, sleep and anesthesia, and general surgery. Welsh earned bachelor’s and master’s degrees in biomedical engineering from Clemson University.