Jae Kim is a senior associate in the FDA Regulatory Group, and advises clients in the medical device, pharmaceutical, food and beverage, hemp and CBD, and consumer products industries.
Jae provides regulatory compliance and risk management advice to companies with products and operations subject to regulation by FDA and other federal agencies, as well as state regulatory authorities. As part of her regulatory practice, she regularly advises clients on regulatory issues that arise throughout the product life cycle, including product development and approval strategy, current good manufacturing practices (cGMPs), state and federal licensing and registration, labeling, advertising and promotion, inspections, agreements pertaining to quality and regulatory issues, recall management, and regulatory enforcement actions.
Jae has extensive experience in conducting regulatory due diligence on behalf of companies seeking to acquire or invest in companies with a portfolio of regulated products. She also has experience in providing strategic regulatory advice and counseling for companies facing internal investigations, litigation, and arbitrations.
Jae serves on the Philadelphia office's Diversity & Inclusion Committee and was selected to represent DLA Piper in the Leadership Council on Legal Diversity (LCLD) 2022 Pathfinder Program. Outside the office, she is actively involved in the regulatory community and serves on the Food and Drug Law Institute (FDLI)'s Cannabis Products Committee as well as the Membership Committee of Women in Bio – Philadelphia Metro Chapter.
Jae's experience includes:
- Serving as regulatory counsel in several internal investigations for biotechnology companies involving allegations of GxP violations;
- Serving as lead regulatory counsel for leading global insurance organization in an arbitration involving FDA representations and warranties;
- Serving as lead regulatory counsel for medical device contract manufacturer to successfully resolve customer audit findings through comprehensive GMP remediation plan;
- Performing legal evaluation and risk assessment of labeling and promotional materials based on FDA and FTC requirements (for medical devices, pharmaceutical products, food and beverage, dietary supplements, cosmetics);
- Drafting quality agreements for all levels of supply chain, including contract manufacturers, contract laboratories, and raw material suppliers (cGMP/ISO standards);
- Drafting clinical trial agreements;
- Providing strategic guidance on FDA's premarket approval or clearance process, including assessment of applicable product classification;
- Advising clients on FDA's adverse event reporting requirements;
- Counseling on state and federal permit and registration issues (FDA, DEA, TTB, CLIA, State Board of Pharmacy, State Health Departments);
- Preparing responses to FDA Form 483 observations;
- Comprehensive review and drafting of quality system, governance, and compliance related SOPs;
- Counseling on Sunshine Act reporting requirements;
- Coordinating regulatory advice from counsel in Canada, Europe, Asia, and Latin America for clients with regulated products in multiple ex-U.S. jurisdictions; and
- Extensive experience in conducting regulatory due diligence on behalf of clients in transactions involving regulated products.
- J.D., University of Notre Dame Law School
- Editor in Chief, Notre Dame Journal of Law, Ethics & Public Policy
- Notre Dame Moot Court Board
- B.A., Johns Hopkins University
- The Legal 500 United States
Recommended, Product Liability, Mass Tort and Class Action: Consumer Products (including Tobacco) (2022)
Recommended, Product Liability, Mass Tort and Class Action: Pharmaceuticals and Medical Devices - Defense (2022)
- Co-author, "Pharma & Medical Device Regulation," Lexology (August 2022)
- Co-author, "What FDA Expects From Medical Device Cybersecurity Efforts," Law360 (April 2022)
- Co-Author, "Cos. Must Heed FDA Warning On Hand Sanitizers," Law 360, (August 2020)
- "[UPDATED] As device industry veterans and newcomers step up to the line, FDA swiftly adjusts regulatory hurdles for personal protective equipment during the COVID-19 pandemic" (April 2020)
- Co-author, "Get Ready For Digital Health Product Liability Cases," Law360 (July 2018)
- Co-author, "Product Liability Implications in the Digital Health Industry," Health Transformer (November 2017)
- Co-author, "Promotion of Precision Medicine Under Imprecise Rules," FDLI Update (2016)
- Co-author, "Public Disclosure Bar Prohibits "Bounty-Hunting" Relators From Filing Duplicative FCA Claims," DLA Piper Litigation Alert (January 2016)
- Panelist, "Best Practices for Implementing a Labeling Change," Advertising and Promotion Regulatory Affairs Conference – Arlington, Virginia, February 23, 2023
- Panelist, "Promoting Diversity and Inclusion through Advertising and Promotion," Food and Drug Law Institute Conference, October 2022
- Panelist, "Cannabis Legislation Proposals, State-Level Legalization, and Regulatory Activity," Food and Drug Law Institute Conference, May 2022
- Presenter, "510(k)’s versus PMA’s: Impacts in Defending Cases Involving Implanted Medical Devices," DRI Drug and Medical Device Litigation Seminar, May 2020
Jae worked as a summer law clerk and a summer associate at the Philadelphia office of DLA Piper.
Memberships And Affiliations
- Women in Bio (Philadelphia Chapter), Membership Co-Vice Chair
- Food and Drug Law Institute, Committee Member
My latest insights
Mandatory biennial FDA food facility registration period is now open until December 31
17 October 2022 .2 minute read