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McCormack Schreiber Legal Search

Healthcare FDA Regulatory/Compliance Associate – Chambers-Ranked Practice –

McCormack Schreiber Legal Search, Chicago, Illinois, United States, 60290


Healthcare FDA Regulatory/Compliance Associate – Chambers-Ranked Practice – Am Law 100 Firm

About the Position:We are working with one of the world’s leading law firms that has an immediate need for a healthcare attorney with FDA regulatory/compliance experience to join its Chicago office. This leading healthcare practice is Chambers-ranked and is one of the largest in the U.S. The attorneys in this group represent a diverse client base, including academic medical centers, pharmaceutical companies, clinic laboratories, physician-hospital organizations, and pharmacies. The practice includes regulatory, litigation, and transactional matters across the country.Highlights:· Chambers-ranked healthcare practice· Recognized as a top firm for healthcare by Vault Law· Ranked in the BTI Consulting’s Client Service A-Team list in 2024 for its outstanding client-centered service· Firm cultivates pro bono partnerships with clients across the countryResponsibilities:· 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 cosmeticsRequired Qualifications:· 3-5 years of FDA regulatory 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 is preferred· Strong academic credentials and excellent writing skills are required

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