Kelsey is a strategic and influential regulatory affairs leader with over nine years of experience shaping global regulatory strategy for medical devices. She has a strong track record of helping innovative products reach the market, including securing an impressive number of FDA 510(k) clearances. 

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Known for her practical, solutions-focused approach, she ensures regulatory requirements are met efficiently while maintaining high standards of compliance throughout the product lifecycle. She works closely with cross-functional teams to navigate complex regulatory pathways, supporting products from early concept right through to commercialisation.

 

"​My area of expertise includes but is not limited to new product development regulatory strategy, FDA 510(k) submissions, product change evaluation, FDA establishment registrations, Health Canada licensure, and OEM / Private Label devices."​

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