FDA Regulatory Attorney - Medical Devices (Junior to Mid)

BCG Attorney Search; Washington (District of Columbia); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Job summary

BCG Attorney Search in Washington, DC seeks a junior to mid-level associate for the Medical Devices group within FDA regulatory practice. You will advise on premarket and post-market compliance, enforcement, and strategic regulatory matters in the medical device sector.

The role emphasizes strong writing, analytical skills, and the ability to navigate evolving FDA pathways, with potential to advance as you gain experience in a dynamic legal landscape.

Qualifications

• Demonstrated interest in FDA regulatory law and medical device issues.
• Experience with FDA medical device matters preferred.
• Admission to the District of Columbia Bar.
• Outstanding writing and analytical skills.
• Strong academic credentials and commitment to excellence.

Responsibilities

• Advise clients on FDA regulatory pathways and compliance strategies.
• Support preparation and submission of premarket applications, including 510(k) notifications and PMAs.
• Assist in navigating FDA review processes and responding to agency inquiries.
• Work on post-market compliance, including recalls and adverse event reporting.
• Engage with evolving legal and policy landscapes for AI-enabled medical devices.
• Develop strategies for bringing innovative technologies to market.

Skills

Strong communication

Problem-solving

Analytical skills

Regulatory writing

Education

Law degree from ABA-accredited law school

Job description

BCG Attorney Search in Washington, DC seeks a junior to mid-level associate for the Medical Devices group within FDA regulatory practice. You will advise on premarket and post-market compliance, enforcement, and strategic regulatory matters in the medical device sector.

The role emphasizes strong writing, analytical skills, and the ability to navigate evolving FDA pathways, with potential to advance as you gain experience in a dynamic legal landscape.