Life Sciences Law Update
Jodi Scott
Partner Global Regulatory
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Overview
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Experience
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Credentials
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Insights and events
Jodi Scott brings extensive experience and a pragmatic perspective, shaped by her tenure as in-house FDA counsel at Medtronic PLC, the world’s largest medical device manufacturer. She advises medical device companies on regulatory compliance, FDA inspections, MDRs, and risk mitigation strategies. A leader in practical FDA compliance, Jodi specializes in enforcement actions, post-market requirements, and quality system regulations (QSR), crafting strategies that align regulatory obligations with business goals.
A certified ISO 13485 auditor, she helps companies prepare for ISO and MDSAP audits and FDA inspections. Jodi also guides medical device manufacturers through state licensing requirements, ensuring seamless market entry. She is a trusted advisor in digital health, AI, and medical device innovation, helping clients integrate emerging technologies while maintaining compliance. Whether developing AI-driven therapeutics and diagnostics or advancing wearable health technologies, she provides strategic guidance to balance innovation and regulation.
She also counsels on medical device recalls, ensuring regulatory obligations align with patient safety and corporate priorities. Her expertise extends to mergers, acquisitions, and financial transactions, conducting regulatory due diligence to support business objectives. As co-leader of the firm’s AI & Digital Health Working Group, Jodi helps clients navigate evolving FDA regulations, ensuring compliance while securing a strategic advantage in the marketplace.
Credentials
Education
- J.D., The Catholic University of America, Columbus School of Law, cum laude, 1998
- B.S., Drake University College of Pharmacy and Health Sciences, 1995
Bar admissions and qualifications
- Colorado
- District of Columbia
- ISO 13485 Certified Auditor
Memberships
- Board Member, Colorado BioScience Association
- Contributing Expert to FDANews Inspection Insider
- Food & Drug Law Institute