FDA Regulatory Associate Attorney

Profile

A law firm seeks an experienced Associate Attorney with 2 to 4 years of experience in FDA regulatory law to join its growing team in Washington, D.C. The ideal candidate will have a strong foundation in regulatory strategy and compliance issues related to FDA-regulated products. This role offers a collaborative and supportive environment, providing associates with the opportunity to directly engage with clients and work on high-stakes matters, including regulatory approvals, compliance, and government investigations.

Duties:

• Develop regulatory strategies to help clients obtain marketing authorization for FDA-regulated products.
• Lead meetings with FDA representatives on behalf of clients seeking product approval or addressing regulatory matters.
• Advise clients on regulatory compliance issues, including complaint handling, recalls, field actions, and promotional reviews.
• Conduct internal investigations and audits to assess clients' adherence to regulatory requirements.
• Respond to government inspections and guide clients through compliance matters with federal agencies.
• Assist with due diligence for transactions, mergers, and securities offerings involving FDA-regulated entities.
• Draft and review complex legal documents, including regulatory filings, policies, and compliance protocols.
• Build and maintain strong client relationships by providing sound legal advice on FDA-related matters.

Requirements:

• 2 to 4 years of experience practicing FDA regulatory law, with a focus on compliance and product approval processes.
• Experience working with medical device regulatory issues is a plus.
• Strong written and verbal communication skills, with the ability to articulate complex legal concepts clearly.
• Ability to work independently while contributing effectively to team projects.
• Experience in conducting internal audits and responding to government inspections.
• Solid background in regulatory strategy, product marketing authorizations, and FDA interactions.
• Must be a member of the District of Columbia Bar or eligible to waive in.

Education:

• Juris Doctorate (JD) from an accredited law school.

Certifications:

• Active membership in the District of Columbia Bar or eligibility to waive in.

Skills:

• In-depth knowledge of FDA regulatory requirements, including approval processes and compliance issues.
• Strong research and writing abilities for drafting complex legal documents.
• Experience in conducting due diligence for transactions and regulatory compliance matters.
• Ability to manage client relationships and communicate effectively with both clients and regulatory agencies.
• Proficiency in handling FDA inspections, audits, and government inquiries.
• Ability to work in a collaborative environment and provide proactive solutions to regulatory challenges.

Benefits:

• Competitive compensation package based on experience.
• Opportunity to work closely with clients and contribute to high-profile regulatory matters.
• Collaborative, boutique firm environment with substantial client interaction and professional development opportunities.
• Health insurance options and other benefits as provided by the firm.

This is an exciting opportunity for an associate looking to build a career in FDA regulatory law within a supportive and dynamic team. If you have experience in regulatory compliance and FDA law, and you’re looking for a firm where you can make a tangible impact, we encourage you to apply.

Company info

BCG Attorney Search
1629 K ST NW, Suite 300
Washington
District of Columbia
United States 20006
Phone : (202) 955-5585
Fax : (213) 895-7306