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Karen Jaenike, in her role as Legal Director in the Strategic Commercial Affairs global legal group at Align Technology, Inc., leads legal strategy for global product commercialization, clinical research, and artificial intelligence governance initiatives. She counsels on Align’s development and deployment of AI technologies, including regulatory risk for AI in medical devices, implementation of global governance frameworks, and cross-functional risk mitigation. Karen brings deep experience in medical device regulation, healthcare compliance, and technology law. Karen began her legal career at Pillsbury Madison & Sutro LLP, now Pillsbury Winthrop Shaw Pittman LLP, and holds a Juris Doctor with distinction from Stanford Law School.