Lyndsay's career began as a medical device product development engineer after receiving a Bachelor's Degree in Materials Science and Engineering from Georgia Institute of Technology (Georgia Tech). Her curiosity and thirst for knowledge led her to ask about the "why" behind regulatory requirements for medical devices, planting a seed which would take several years to grow. After successfully serving as a medical device project technical lead and project manager, she transitioned into the world combination products as an engineer and subsequently shifted into a role in regulatory affairs. Lyndsay has over a decade of experience and brings a fresh and unique perspective to regulatory strategy, writing, and compliance, based on her background in combination product and medical device engineering, product development, project management, and regulatory affairs. Specific areas of expertise include Human Factors, Design Controls, 21 CFR Part 4 (Combination Product cGMP), EU MDR/Article 117, Health Authority interaction, labeling, dossier writing and global strategy. Lyndsay truly believes in the role regulatory affairs plays to ensure that those in need of medical diagnosis, treatment, or monitoring around the world are provided with safe and efficacious products.