Role
Director of Regulatory Affairs
Qualifications
Bachelor of Science
(Biomedical Engineering)
(Georgia Institute of Technology)
Juris Master
(Emory University School of Law)
Registered Patent Agent
(USPTO Reg. 76,515)
Capabilities
Regulatory Strategy and Submissions, Intellectual Property Strategy, Risk Management
Alexandra Smythe
Alexandra has nearly a decade of experience deeply involved in all phases of the medical device product lifecycle, managing both the global regulatory strategy and the intellectual property portfolio for a major innovator in the radiotherapy and diagnostic imaging industry. With a unique background combining engineering and law, she carefully balances ever-changing regulatory requirements with strategic business objectives. Alexandra particularly enjoys advocating for new and exciting technologies that address unmet clinical needs and communicating their value to regulators, auditors, patent examiners, and investors. She is also passionate about sharing her regulatory and legal knowledge with others to set them up for future success.
Alexandra is based out of our US office in the Philadelphia suburbs. Outside of work, she enjoys spending time with her spouse, painting and drawing in both traditional and digital media, antiquing, and baking all kinds of delicious treats.