FDA - Health Care Associate Attorney

2-9 yrs required

Full-time

No

Job Overview: A law firm in Washington, ., is seeking an FDA - Health Care Associate Attorney with 4-6 years of experience and a strong background in drug and medical device regulatory compliance issues, particularly in current good manufacturing practice (CGMP) matters. The ideal candidate will have prior industry experience in pharmaceutical manufacturing or a scientific background in analytical chemistry, chemical engineering, or microbiology. Experience at the Food and Drug Administration is a plus. Exceptional academic credentials and interpersonal skills are essential for this role.

Duties:

• 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.

Requirements:

• Bachelor's degree in Law or related field.
• Juris Doctor (JD) from an accredited law school.
• Admission to the Bar in Washington, ., or eligibility for admission through reciprocity.
• 4-6 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.
• Excellent written and verbal communication skills.
• Exceptional analytical and problem-solving abilities.
• Ability to work effectively in a fast-paced environment and handle multiple tasks simultaneously.
• Strong attention to detail and accuracy.

Education:

• Bachelor's degree in Law or related field.
• Juris Doctor (JD) from an accredited law school.

Certifications:

• Admission to the Bar in Washington, ., or eligibility for admission through reciprocity.

Skills:

• Proficiency in legal research and analysis.
• Excellent drafting and reviewing skills.
• Strong understanding of FDA regulations.
• Interpersonal skills for effective collaboration with internal teams and clients.
• Ability to stay updated on industry trends and regulatory developments.

Legal