Marina Sirras & Associates LLC
Healthcare Attorney (FDA/Regulatory Focus)
Marina Sirras & Associates LLC, Washington, District of Columbia, United States
Healthcare Associate - Washington DC Our client, an AMLAW 100 firm, is seeking an FDA Associate with 4-5 years of experience to join their Healthcare Practice Group in Washington DC. The estimated salary for this position is $310,000-$365,000 (annually) and may vary depending on experience and other factors. Responsibilities: Provide legal advice and support on FDA regulatory matters related to drug and medical device compliance Conduct legal research and analysis on current good manufacturing practice (CGMP) issues and other FDA regulations Draft and review legal documents, including regulatory submissions, compliance policies, and contracts Collaborate with internal teams and clients to develop regulatory strategies and ensure compliance with FDA requirements Represent clients in FDA inspections, investigations, and enforcement actions Stay updated on developments in FDA regulations and industry trends Qualifications: 4-5 years of experience in FDA regulatory compliance, preferably in a law firm or corporate setting Strong understanding of FDA regulations matters, particularly in current good manufacturing practice (CGMP) Prior industry experience in pharmaceutical manufacturing or a scientific background in analytical chemistry, chemical engineering, or microbiology is strongly preferred Experience at the Food and Drug Administration is a plus Exceptional analytical, communication, and problem-solving abilities Ability to work effectively in a fast-paced environment and handle multiple tasks simultaneously Strong attention to detail and accuracy JD from an accredited university and excellent academic credentials Must be barred in the District of Columbia, or eligible for admission through reciprocity or UBE score transfer All candidates must be authorized to work in the U.S.