News
Biotech & Digital Medicine Showcase: Life sciences firms advised on regulatory concerns, investing
25 January 2021
PartnerDenver
Email jodi.scott@hoganlovells.com
Phone +1 303 454 2463
Fax +1 303 899 7333
Practice groupGlobal Regulatory
Jodi Scott developed and honed her practical, real-world sensibility and business acumen during the time she spent as an in-house FDA counsel with the world's largest medical device manufacturer.
Today, she uses that background to solve the challenges that confront her clients in areas that include MDRs, regulatory due diligence, importing and exporting medical devices, advertising and promotion, preparing for and managing FDA inspections, and developing systems to mitigate the risks associated with the unapproved use of approved products (AKA off-label uses).
Jodi assists the medical device industry in navigating the complex requirements so as to maintain compliance with the U.S. Food and Drug Administration's (FDA) quality system (QSR) and other post-market regulatory rules. She spends much of her time developing and implementing strategies to manage FDA-initiated enforcement actions, such as FDA inspections that result in FDA Form 483s, untitled letters, Warning Letters, investigations, and consent degrees of permanent injunction. She has received ISO 13485 auditor certification and assists companies in preparing for managing and responding to ISO and MDSAP audits.
She also guides her clients through complex medical device recalls by helping them work through the difficult decisions of whether a recall is warranted and, if so, how to execute it in a way that best achieves a balance between patient and customer risk and the agency's interests, while also demonstrating the company's commitment to safety and its regulatory obligations.
She also applies her regulatory knowledge in assisting clients with regulatory due diligence related to mergers and acquisitions and funding, such as private equity deals, initial public offerings, and other financial transactions.
Finalist, Outstanding Women in Business
Denver Business Journal
Life Sciences Star
LMG Life Sciences
Lawyer of the Year
Law Week Colorado
Best Life Science Lawyer - Colorado
The Corporate America M&A Awards
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
Memberships
Board Member and Chair of the Board Governance Committee, Girl Scouts of Colorado
Colorado BioScience Association
Contributing Expert to FDANews Inspection Insider
Food & Drug Law Institute
Bar admissions and qualifications
Colorado
District of Columbia
ISO 13485 Certified Auditor
News
25 January 2021
News
22 January 2021
Hogan Lovells Publications
21 January 2021
News
15 January 2021
Media Mention
14 January 2021
Sponsorships and Speaking Engagements
11-15 January 2021