Venable LLP · 2 days ago
FDA Associate
Washington, DC
Full-time
Onsite
Mid Level
3+ years expVenable LLP is a well-regarded law firm specializing in Food & Drug Law, and they are seeking a midlevel associate to join their FDA Group in Washington, D.C. The role involves advising clients on regulatory, compliance, and enforcement matters related to food, dietary supplements, medical devices, and prescription drugs.
AdviceLegalService Industry
Responsibilities
FDA regulatory counseling involving foods, dietary supplements, OTC drugs, cosmetics, and medical devices and prescription drugs, including product classification, labeling, and compliance strategy
Medical device regulatory matters, including premarket pathways, 510(k)s and labeling and promotional compliance, post-market obligations, inspections, and enforcement risk
FTC advertising and marketing compliance, including claims substantiation, labeling review, and promotional risk assessments; civil investigative demands (CIDs); access letters
National Advertising Division (NAD) proceedings, defense and challenges, and compliance counseling
Advertising claims substantiation, including ingredient and product assessments
Class action and pre-litigation consumer protection matters, including CLRA demand letters, litigation risk assessments, and coordination with litigation teams
State AG and DA inquiries, subpoenas, and investigations
FDA inspections, warning letters, recalls, and enforcement actions
Import/export issues and supply chain compliance
Ingredient reviews, including NDIs, and regulatory status assessments
California Proposition 65 compliance
Good manufacturing practice (GMP) regulations
Prescription drug labeling and promotional compliance, including FDA advertising and promotion considerations
Qualification
Required
Minimum of three years of experience practicing in a law firm or comparable regulatory setting
Strong legal writing, research, and analytical skills
Collaborative, proactive, detail-oriented
Comfortable handling matters independently while working closely with senior attorneys and clients
Juris Doctor degree from an accredited law school
Admitted to and in good standing with the D.C. Bar (or eligible for prompt admission)
Experience with FDA regulatory counseling involving foods, dietary supplements, OTC drugs, cosmetics, and medical devices and prescription drugs
Experience with medical device regulatory matters, including premarket pathways, 510(k)s and labeling and promotional compliance, post-market obligations, inspections, and enforcement risk
Experience with FTC advertising and marketing compliance, including claims substantiation, labeling review, and promotional risk assessments
Experience with National Advertising Division (NAD) proceedings, defense and challenges, and compliance counseling
Experience with advertising claims substantiation, including ingredient and product assessments
Experience with class action and pre-litigation consumer protection matters, including CLRA demand letters, litigation risk assessments, and coordination with litigation teams
Experience with state AG and DA inquiries, subpoenas, and investigations
Experience with FDA inspections, warning letters, recalls, and enforcement actions
Experience with import/export issues and supply chain compliance
Experience with ingredient reviews, including NDIs, and regulatory status assessments
Experience with California Proposition 65 compliance
Experience with Good manufacturing practice (GMP) regulations
Experience with prescription drug labeling and promotional compliance, including FDA advertising and promotion considerations
Company
Venable LLP
Venable provides advisory and legal solutions to businesses, organizations, and individuals.
1001-5000 employees
H1B Sponsorship
Venable LLP has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
2023 (4)
2022 (1)
2021 (3)
2020 (12)
Funding
Current Stage
Late StageLeadership Team
A
Andrew Hales
Vice President - Professional Development & Training
Christopher Boone
Counsel
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