Jae Kim

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.

• 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)