Healthcare Associate ? FDA & Life Sciences

Recruiter

Chicago, IL

Healthcare Associate ? FDA & Life Sciences

Attorney

2-10 yrs required

No

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.LocationChicago, IllinoisDutiesAdvise on FDA regulatory compliance across the product lifecycle, from preclinical development to commercializationProvide guidance on product approvals, labeling, manufacturing practices, and regulatory inspectionsManage compliance and documentation for adverse events, recalls, and responses to FDA Form 483Support clients with contract drug and device manufacturing, quality agreements, and due diligence for life sciences transactionsAdvise on compliance with DSHEA, the Food, Drug, and Cosmetic Act, the Federal Trade Commission Act, and other relevant regulatory frameworksAssist clients in navigating state Board of Pharmacy regulations, market denial orders, and telemedicine-based drug delivery complianceContribute to litigation-adjacent advisory roles for life sciences clientsRequirements3 to 5 years of experience in FDA regulatory compliance, specifically within healthcare and life sciencesExperience in regulatory areas such as product approvals, inspections, adverse events, quality agreements, and advertising practicesBackground in servicing life sciences industry clients, with an understanding of client needs and regulatory landscapesPrior work experience in a sophisticated law firm or healthcare environment, or at the FDA or a life sciences companyEducationJuris Doctor (.) from an accredited law school with excellent academic credentialsCertificationsActive license to practice law in Illinois or eligibility to obtain licensure in IllinoisSkillsStrong knowledge of FDA regulations and compliance requirements for healthcare and life sciencesProficient in regulatory documentation, product lifecycle management, and legal researchExceptional writing and analytical skillsAbility to effectively communicate complex regulatory issues to clientsBenefitsOpportunities for professional growth and mentorship within a collaborative environmentRecognition and support in a top-ranked healthcare and life sciences legal teamExposure to diverse clients and regulatory challenges across the healthcare sector