Karen brings a very unique background that brings more than 30 years of technology project management and regulatory operations and strategy experience with medical device development, combination product and drug focus.
Karen brings a very unique background that brings more than 30 years of technology project management and regulatory operations and strategy experience with medical device development, combination product and drug focus. She has led multi-stakeholder teams for over 12 years across multiple disciplines and indications including submissions, health authority interaction as well as clinical programs and quality system updates. In her 15+ years as a regulatory professional, she has led multinational clinical studies for an implanted neurostimulation device, a cerebral embolic protection device (combination device led), intragastric device and numerous orthopedic devices. She has interfaced with global regulatory authorities for clinical trial submissions as well as approval and clearance negotiations. Karen recently achieved the submissions of two INDs for a drug led combination product resulting in Study May Proceed letters – one with fast-track designation – within 30 days. Karen has interacted with both the drug and device branches of the FDA for IND, PMR, label negotiations, IDE and post market submissions, BLA/NDA, biosimilar, combination product, PMA, and 510K pathways. Karen has ensured manufacturing efficiencies by extending product shelf life and implementing creative UDI solutions for combination products. She is familiar with the need to execute efficient clinical programs that not only bring needed therapies to market but also ensure that the regulatory strategy and resulting label claims will support the commercial program. Karen holds an undergraduate degree in Computer Science from Georgia Tech, a Masters degree in Electrical Engineering from Cornell, an MBA from NYU, a Masters in Regulatory Science from USC and is working towards a degree in Health Law from NYU in 2025. Karen was born in Montreal and lives in Irvine with her husband and golden doodle and they have three grown children.