Healthcare Associate FDA & Life Sciences

Job Overview:
A leading national law firm is seeking a Healthcare Associate with a strong background in FDA regulatory compliance and life sciences. This role is part of a highly respected team recognized for providing business-focused healthcare solutions across various sectors, including pharmaceutical, medical devices, dietary supplements, and biotechnology. The ideal candidate will have experience with FDA regulations and the broader regulatory framework surrounding healthcare and life sciences, supporting clients in navigating complex legal and compliance requirements.

Location

• Chicago, Illinois

Duties

• Advise on FDA regulatory compliance across the product lifecycle, from preclinical development to commercialization
• Provide guidance on product approvals, labeling, manufacturing practices, and regulatory inspections
• Manage compliance and documentation for adverse events, recalls, and responses to FDA Form 483
• Support clients with contract drug and device manufacturing, quality agreements, and due diligence for life sciences transactions
• Advise on compliance with DSHEA, the Food, Drug, and Cosmetic Act, the Federal Trade Commission Act, and other relevant regulatory frameworks
• Assist clients in navigating state Board of Pharmacy regulations, market denial orders, and telemedicine-based drug delivery compliance
• Contribute to litigation-adjacent advisory roles for life sciences clients

Requirements

• 3 to 5 years of experience in FDA regulatory compliance, specifically within healthcare and life sciences
• Experience in regulatory areas such as product approvals, inspections, adverse events, quality agreements, and advertising practices
• Background in servicing life sciences industry clients, with an understanding of client needs and regulatory landscapes
• Prior work experience in a sophisticated law firm or healthcare environment, or at the FDA or a life sciences company

Education

• Juris Doctor (J.D.) from an accredited law school with excellent academic credentials

Certifications

• Active license to practice law in Illinois or eligibility to obtain licensure in Illinois

Skills

• Strong knowledge of FDA regulations and compliance requirements for healthcare and life sciences
• Proficient in regulatory documentation, product lifecycle management, and legal research
• Exceptional writing and analytical skills
• Ability to effectively communicate complex regulatory issues to clients

Benefits

• Opportunities for professional growth and mentorship within a collaborative environment
• Recognition and support in a top-ranked healthcare and life sciences legal team
• Exposure to diverse clients and regulatory challenges across the healthcare sector

This international law firm has 20 offices with over 900 attorneys on its team. Its service areas include financial services litigation, technology and outsourcing, healthcare law, government, criminal and regulatory investigations, real estate and land use, environmental, energy law, insolvency and restructuring, product liability and mass torts, corporate, private wealth services, employee benefits, banking and finance, patents, labor and employment, intellectual property, class action and antitrust and trade regulation.