Healthcare Associate FDA & Life Sciences

Job Overview:
A distinguished national law firm seeks an experienced Healthcare Associate with a background in FDA regulatory compliance and life sciences for its Charlotte office. This role offers the opportunity to work within a leading AmLaw 100 team known for its innovative and client-focused healthcare solutions. The ideal candidate will have experience navigating the complex regulatory frameworks within the healthcare and life sciences industries, including compliance with FDA regulations, state Boards of Pharmacy regulations, and other key legal standards.

Location

• Charlotte, North Carolina

Duties

• Provide comprehensive legal guidance on FDA regulatory compliance across all stages of product development, from preclinical phases through commercialization
• Oversee regulatory aspects of product approvals, labeling, inspections, manufacturing, recalls, and adverse event management
• Support clients with contract drug and device manufacturing, quality agreements, and regulatory due diligence for life sciences transactions
• Advise on compliance with DSHEA, the Food, Drug, and Cosmetic Act, and the Federal Trade Commission Act
• Counsel clients on state Boards of Pharmacy regulations, FDA market denial orders, and telemedicine-based drug delivery
• Serve as an advisor in litigation-adjacent roles for clients in life sciences

Requirements

• 3 to 5 years of experience in FDA regulatory compliance within healthcare and life sciences
• Expertise in regulatory documentation, including responses to FDA Form 483, quality agreements, and compliance for medical devices, pharmaceuticals, and dietary supplements
• Demonstrated experience working with clients in the life sciences sector and understanding industry-specific regulatory needs
• Prior experience in a sophisticated law firm, the FDA, or a life sciences company is preferred

Education

• Juris Doctor (J.D.) degree from an accredited law school
• Strong academic credentials

Certifications

• Active law license in North Carolina or eligibility to obtain licensure in North Carolina

Skills

• Proficient in regulatory compliance, FDA regulations, and industry-specific legal research
• Strong analytical and communication skills for effectively advising clients
• Solid writing skills for preparing detailed regulatory documentation and legal opinions

Benefits

• Mentorship and professional development within a collaborative, nationally-ranked healthcare and life sciences team
• Exposure to high-profile clients and innovative legal matters across healthcare

This is a full-service AmLaw 100 firm with a growing Charlotte office. The associates here work normal hours and get top pay. They are given sophisticated work and client contact early in their careers. These partners truly mentor their associates. It is not uncommon for these associates to have an open and honest dialogue with their partners about the firm, the office and the work. Although this firm is highly selective, once you are in, you wont want to leave. We like this firm a lot and have very good relationships here.