Background
Sarah brings five years of combined regulatory and industry knowledge to MCRA’s team. She is equipped with extensive knowledge of the regulatory space and submission timelines as well as product development, quality manufacturing, DFMEA, PFMEA, IQ/OQ/PQ and product and process verification/validation procedures. As a senior regulatory associate, Sarah’s primary focus is to develop regulatory strategy and author the supporting regulatory documentation to attain clearance/approval for clients.
Education
Sarah holds a Master of Engineering in Biomedical Engineering from Clemson University as well as a Bachelor of Science in Biomedical Engineering from Clemson University.
Experience
Prior to joining MCRA in February 2022, Sarah worked in industry focusing largely on product development, technological transfer, and process and product development. Through previous roles, Sarah is seasoned in performing DFMEA/PFMEA, IQ/OQ/PQ, and product and process validation and verification.
Sarah Welsh is responsible for the development of Q-Submissions, 510(K)s, De Novos, Breakthrough Device Requests, and PMAs for clients. Sarah also works to develop regulatory strategies, product landscape analyses, as well as recommendations for pre-clinical testing and clinical data requirements. Additionally, she is very experienced with literature analysis and evaluations. Sarah also has experience in drafting and preparing international (EU) regulatory submissions, notably, Clinical Evaluation Reports. Sarah brings technical writing skills and regulatory strategy knowledge to MCRA’s regulatory team. She has worked in several therapy areas including spine, orthopedic, wound care, biocompatibility, and anesthesia as well as with cross-therapy devices and devices outside MCRA’s standard therapy divisions.