FDA Regulation Associate Attorney

2-14 yrs required

Full-time

No

A law firm in Seattle is seeking an FDA Regulation Associate Attorney with 5-10 years of broad experience in counseling companies with FDA-regulated products. The successful candidate will be responsible for reviewing contracts and supporting corporate deals involving regulated companies in this dynamic field.

Duties:

• Provide legal counsel to companies with FDA-regulated products on compliance matters and regulatory requirements.
• Review and negotiate contracts, agreements, and other legal documents pertaining to FDA-regulated products.
• Assist in due diligence reviews for corporate transactions involving FDA-regulated companies.
• Analyze FDA regulations and guidance documents to provide strategic advice and risk assessments.
• Advise clients on labeling, advertising, and promotional activities in compliance with FDA regulations.
• Handle FDA inspections, responses to FDA warning letters, and other regulatory enforcement matters.
• Stay updated on changes in FDA regulations and industry trends to provide proactive legal guidance.

Requirements:

• Juris Doctor (JD) degree from an accredited law school.
• Admission to the State Bar and eligibility to practice law in Washington.
• 5-10 years of experience in counseling companies with FDA-regulated products.
• Strong understanding of FDA regulations and requirements applicable to pharmaceuticals, medical devices, or other regulated products.
• Experience reviewing contracts and supporting corporate deals involving regulated companies.
• Excellent communication, negotiation, and analytical skills.
• Ability to work independently and collaboratively within a team environment.

Education:

Juris Doctor (JD) degree from an accredited law school.

Certifications:

Admission to the State Bar and eligibility to practice law in Washington.

Skills:

• In-depth knowledge of FDA regulations and guidance documents.
• Strong contract review and negotiation skills.
• Ability to provide strategic legal advice and risk assessments.
• Excellent written and verbal communication skills.
• Detail-oriented with strong analytical capabilities.
• Proficiency in managing multiple priorities and deadlines effectively.

Legal