about
Lyndsay Sweeney
Founder and Primary Consultant
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, leading to collaboration with regulatory affairs colleagues from the beginning of her career. 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 products and medical device engineering, product development, project management, and regulatory affairs. Lyndsay truly believes in the role regulatory affairs plays to ensure that those in need of medical diagnosis, treatment, or monitoring are provided with safe and efficacious products.
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Available for fractional, contract, project-based, and advisory engagements.
