Mid-Level FDA Healthcare Associate

Overview

• Supports a regulatory partner whose practice integrates FDA-regulated product counseling, healthcare compliance, commercial contracting, corporate transactions, enforcement risk management, and cross-border strategy.
• Advises global life sciences, healthcare, technology, and investor clients on complex regulatory matters affecting drugs, biologics, medical devices, diagnostics, digital health technologies, cosmetics, food, and tobacco products.
• Addresses healthcare regulatory regimes including reimbursement, provider operations, telemedicine, pharmacy regulation, laboratory oversight, DEA compliance, and privacy.
• Conducts and manages regulatory due diligence for corporate transactions (mergers, acquisitions, divestitures, investments, joint ventures, strategic alliances) involving healthcare and life sciences businesses.
• Supports the drafting, review, and negotiation of regulatory and quality provisions in commercial arrangements, including manufacturing and supply, CDMO, distribution, commercialization, quality/technical, pharmacovigilance, safety data exchange, licensing, collaboration, co-promotion, and services agreements.
• Conducts and oversees legal research on FDA regulation, healthcare compliance, reimbursement, drug pricing, market access, government price reporting, privacy, artificial intelligence governance, and enforcement risk.
• Requires strong transactional judgment combined with a practical understanding of FDA and healthcare regulatory frameworks.
• Requires experience representing buyers, sellers, and financial sponsors in domestic and cross-border mergers, acquisitions, divestitures, and joint ventures.
• Meaningful experience with pharmaceutical, biotechnology, medical device, diagnostic, digital health, healthcare provider, pharmacy, or laboratory businesses is strongly preferred.
• Familiarity with FDA regulatory frameworks, including product approval/clearance/authorization pathways, clinical research, labeling/promotion, quality systems, manufacturing, and post-market requirements.