Midlevel Associate for a Food and Drug Law practice in Washington, DC.
Requires a minimum of 4 years of experience advising life sciences companies on U.S. FDA regulatory matters.
Counsel clients on complex FDA regulatory issues for drugs, biologics, medical devices, and combination products throughout the product development lifecycle.
Interpret and apply federal statutes (FD&C Act, PHSA), regulations, and guidance to specific product development efforts and legal challenges.
Draft and review legal, scientific, and technical materials for FDA regulatory strategies, submissions (e.g., INDs, NDAs, BLAs, EUAs, 510(k), PMA), and agency engagement.
Advise on GxP compliance, expedited approval pathways, marketing exclusivity, labeling, REMS, advertising/promotion, and FDA compliance/enforcement actions (e.g., Form 483s, warning letters).
Support regulatory advocacy, FDA rulemaking, and legislative or policy developments affecting the FD&C Act and PHSA.
Counsel on public-private R&D partnerships with federal agencies (e.g., DoD, BARDA, NIH) and draft related research, development, and commercialization agreements (e.g., CRADAs, FAR/DFAR contracts, MTAs).
Candidates must possess strong analytical, regulatory drafting, and client-service skills.
Juris Doctorate from an accredited law school and active bar admission in good standing are required.
A technical degree (e.g., biochemistry, mechanical engineering) or exposure to adjacent legal areas (e.g., CMS coverage/reimbursement, IP prosecution) is advantageous.
Salary range: $215,000 to $355,000.

February 10, 2026

FDA Associate - Drugs, Biologics, Medical Devices (Mid-Level)

FDACompliance/RegulatoryMedical Devices

Venable LLPDistrict of Columbia

Practice area

FDA · Compliance/Regulatory · Medical Devices

PQE

4-6 years

Location

District of Columbia, District of Columbia

Employment type

Full-time

Overview

Midlevel Associate for a Food and Drug Law practice in Washington, DC.
Requires a minimum of 4 years of experience advising life sciences companies on U.S. FDA regulatory matters.
Counsel clients on complex FDA regulatory issues for drugs, biologics, medical devices, and combination products throughout the product development lifecycle.
Interpret and apply federal statutes (FD&C Act, PHSA), regulations, and guidance to specific product development efforts and legal challenges.
Draft and review legal, scientific, and technical materials for FDA regulatory strategies, submissions (e.g., INDs, NDAs, BLAs, EUAs, 510(k), PMA), and agency engagement.
Advise on GxP compliance, expedited approval pathways, marketing exclusivity, labeling, REMS, advertising/promotion, and FDA compliance/enforcement actions (e.g., Form 483s, warning letters).
Support regulatory advocacy, FDA rulemaking, and legislative or policy developments affecting the FD&C Act and PHSA.
Counsel on public-private R&D partnerships with federal agencies (e.g., DoD, BARDA, NIH) and draft related research, development, and commercialization agreements (e.g., CRADAs, FAR/DFAR contracts, MTAs).
Candidates must possess strong analytical, regulatory drafting, and client-service skills.
Juris Doctorate from an accredited law school and active bar admission in good standing are required.
A technical degree (e.g., biochemistry, mechanical engineering) or exposure to adjacent legal areas (e.g., CMS coverage/reimbursement, IP prosecution) is advantageous.
Salary range: $215,000 to $355,000.

Trusted recruiters

Work with a recruiter who has a real relationship with the hiring team and comes recommended by your peers.

Top recruiter for this opening
Evan Fox
Legal Recruiter
Long Ridge Partners
Why talk to Evan Fox?
Helen Chen joined Venable LLP's District of Columbia office in the Compliance/Regulatory group.
Evan is extremely knowledgeable about the legal job market and its major players and processes. He was able to quickly gauge my interests and strengths and propose helpful suggestions to improve my resume and interviewing tactics. He was very responsive through all mediums and went above and beyond in following up on the progress of my application. After I received an offer, Evan continued to act as a liaison to ensure a smooth transition and start date.
Helen Chen
Venable LLP • District of Columbia
Top recruiter for this opening
Jessica Pai
Legal Recruiter
McClure Harrison, Inc.
Why talk to Jessica Pai?
Alvin Lee joined Venable LLP's District of Columbia office in the Intellectual Property group.
I highly recommend Jessica. Her help was invaluable in placing me in my current position. Besides all the praises others have already listed here, I appreciate that Jessica maintained the relationship and continued to check in after the placement to ensure that I am happy with the move. I have and will continue to refer her to my colleagues who are interested in lateral opportunities.
Alvin Lee
Venable LLP • District of Columbia

Trusted recruiters

Work with a recruiter who has a real relationship with the hiring team and comes recommended by your peers.

Top recruiter for this opening
Evan Fox
Legal Recruiter
Long Ridge Partners
Why talk to Evan Fox?
Helen Chen joined Venable LLP's District of Columbia office in the Compliance/Regulatory group.
Evan is extremely knowledgeable about the legal job market and its major players and processes. He was able to quickly gauge my interests and strengths and propose helpful suggestions to improve my resume and interviewing tactics. He was very responsive through all mediums and went above and beyond in following up on the progress of my application. After I received an offer, Evan continued to act as a liaison to ensure a smooth transition and start date.
Helen Chen
Venable LLP • District of Columbia
Top recruiter for this opening
Jessica Pai
Legal Recruiter
McClure Harrison, Inc.
Why talk to Jessica Pai?
Alvin Lee joined Venable LLP's District of Columbia office in the Intellectual Property group.
I highly recommend Jessica. Her help was invaluable in placing me in my current position. Besides all the praises others have already listed here, I appreciate that Jessica maintained the relationship and continued to check in after the placement to ensure that I am happy with the move. I have and will continue to refer her to my colleagues who are interested in lateral opportunities.
Alvin Lee
Venable LLP • District of Columbia

Last updated: May 21, 2026

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