Jodi Scott

Jodi Scott

Partner
Denver

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 MDSAAP 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.

Awards and recognitions

2013-2019

Life Sciences Star
LMG Life Sciences

2017

Lawyer of the Year
Law Week Colorado

2015

Best Life Science Lawyer - Colorado
The Corporate America M&A Awards

Education and admissions

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

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