Amanda Johnston, J.D., R.A.C.
Amanda Johnston specializes in counseling medical technology and pharmaceutical companies on FDA law, healthcare compliance programs, and fraud and abuse laws.
She assists clients with building and strengthening healthcare compliance programs and all matters related to the Food Drug and Cosmetic Act, AdvaMed and PhRMA Codes, Anti-Kickback Statute, False Claims Act, Sunshine Act and other state transparency laws, HIPAA, Civil Monetary Penalties Law, Stark Law, FTC regulations, and other state and federal healthcare laws.
Prior to joining Gardner Law, Amanda served as North American Compliance Officer at Coloplast Corp., a global medical device company, where she was instrumental in developing and advancing the North American compliance program. Amanda also previously worked in Regulatory Affairs at Medtronic and in Compliance at UnitedHealth Group.
Amanda clearly and effectively communicates realistic and relevant legal advice to business partners to help build compliant commercial programs and ensure appropriate interactions with healthcare professionals. In addition, Amanda draws upon her broad experience to deliver effective compliance training and draft policies and procedures on compliance and regulatory topics.
Amanda has an extensive background with post-market pharmaceutical and medical device regulatory requirements, including change control, ad/promo review, pre-submissions, and PMA and NDA submissions. She also counsels clients on field corrective actions/recalls, CAPAs, and how to appropriately react and respond to adverse FDA actions such as FDA-483s, warning letters, and consent decrees, among other enforcement actions.
Amanda earned her Juris Doctor from the University of Minnesota Law School (Minneapolis, MN), where she concentrated in Health Law & Bioethics. She earned her Bachelor of Arts in Criminology (Summa Cum Laude) from the University of Minnesota Duluth (Duluth, MN). Amanda is also Regulatory Affairs Certified (RAC) through the Regulatory Affairs Professionals Society.
Office: (651) 430-7150
Mobile: (763) 639-6951