With around 10 years of experience in orthopedics, medical devices, and regulatory affairs, Hannah Irwin is a Director of Regulatory Affairs at MCRA. Ms. Irwin is a seasoned regulatory expert with proficiency in U.S. and international medical device regulations. Ms. Irwin specializes in regulatory strategy, writing of regulatory submissions, analysis of pre-clinical and clinical data, development and execution of systematic literature searches, and drafting and reviewing of Clinical Evaluation Reports.
Ms. Irwin holds a Bachelor of Science in Biology from James Madison University.
Prior to join MCRA in October 2015, Ms. Irwin worked in clinical and regulatory affairs for an orthopedic device start up company.
Ms. Irwin’s work at MCRA focuses primarily on both international and U.S. medical devices with a specialization in orthopedics and spine.