Healthcare Associate Attorney

Job Title

Healthcare Associate Attorney

Job Overview

A prestigious law firm based in Washington, D.C., is seeking a Healthcare Associate Attorney specializing in FDA regulatory compliance. The ideal candidate will bring extensive expertise in drug and medical device regulations, particularly in current good manufacturing practice (CGMP) matters. This role involves advising clients across the spectrum of FDA-regulated products, including drugs, devices, biologics, and more.

Duties

• Provide legal guidance on FDA regulatory compliance for drugs and medical devices.
• Conduct in-depth research and analysis of CGMP issues and other FDA regulatory requirements.
• Draft and review legal documents such as regulatory submissions, compliance policies, and agreements.
• Collaborate with clients and internal teams to develop regulatory strategies and ensure adherence to FDA standards.
• Represent clients during FDA inspections, investigations, and enforcement actions.
• Monitor and interpret updates to FDA regulations and industry developments.

Requirements

• 4-5 years of professional experience in FDA regulatory compliance within a law firm or corporate setting.
• Strong knowledge of FDA regulations, with a focus on CGMP.
• Background in pharmaceutical manufacturing or relevant scientific disciplines (e.g., analytical chemistry, chemical engineering, microbiology) is highly preferred.
• Previous experience at the Food and Drug Administration (FDA) is a plus.
• Must be licensed to practice law in the District of Columbia or eligible for admission through reciprocity or UBE score transfer.
• Exceptional problem-solving skills and a keen attention to detail.
• Strong academic credentials with excellent verbal and written communication abilities.
• Ability to manage multiple priorities in a dynamic, fast-paced environment.

Education

• Juris Doctor (JD) from an accredited law school.
• Bar admission in the District of Columbia or eligibility for admission through reciprocity.

Certifications

• Active license to practice law in the District of Columbia.

Skills

• Expertise in FDA regulatory frameworks, particularly CGMP compliance.
• Analytical and research skills to interpret complex legal and regulatory issues.
• Strong interpersonal skills for client and team collaboration.
• Precision and attention to detail in drafting legal documents.

Job Location

• Washington, D.C.

Ranked as a Vault Law 100 international law firm, attorneys at this firm win by understanding their client's business, investing in their success, and by putting their interest ahead of their own. Associates boast working with brilliant attorneys, who are easy to work with, as well as having the opportunity for exciting, substantive legal work. The firm partners with leaders around the world to fuel missions, knock down barriers, and shape markets. The attorneys at this firm bring their personal passion and legal prowess to bear in every matter for their clients and the people they serve. Associate remark the firm is invested in their career destination and want to see the associates' career blossom. There is an opportunity to really grow, and the partners at the firm mentor associates and really care. The happiness factor is one of the firm's top priorities. As one associate put it, the firm is energized and it is an exciting place to be. The firms boasts a tightly-woven network of legal thought leaders who marry their passion for business with a deep, focused understanding of the law. Through their pro bono legal services, volunteer services, and charitable giving, lawyers at this firm are committed to giving back. This firm has been nationally ranked in 33 practice areas by US News.