Healthcare FDA Regulatory/Compliance Associate (3-5 yrs) – Am Law 100 Firm

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Job Overview

About the Position:
Our client, a top law firm in the healthcare space, is seeking a healthcare attorney with FDA regulatory/compliance experience to join its Chicago office as an associate. This leading healthcare practice is one of the largest in the U.S. and handles regulatory, litigation, and transactional matters. Attorneys in the group represent a diverse client base, including academic medical centers, pharmaceutical companies, clinic laboratories, physician-hospital organizations, and pharmacies.

Highlights:
· Chambers-ranked healthcare practice
· Recognized as a top firm for healthcare by Vault Law
· Firm cultivates pro bono partnerships with clients across the country

Responsibilities:
· Advise on product development and approvals, labeling, inspections, manufacturing, recalls, and 483 responses
· Manage adverse event reporting, contract drug and device manufacturing, quality agreements, and life sciences diligence for acquisitions
· Ensure compliance with the DSHEA, Food Drug and Cosmetics Act, Federal Trade Commission Act, and regulations on advertising and promotional practices for devices, drugs, dietary supplements, biologics, and cosmetics

Required Qualifications:
· 3-5 years of FDA/life sciences regulatory and compliance experience
· Familiarity with clients in the life sciences sector, and previous employment at a law firm, FDA, or life sciences company
· Life sciences coursework and experience in litigation-adjacent roles within life sciences preferred
· Strong academic credentials and excellent writing skills are required

Location:
Chicago (Hybrid)

Compensation:
The anticipated base salary range for this position is $260,000 – $365,000.

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