Medical Device & Technology Associate Attorney

Medical Device & Technology Associate Attorney

Direct Counsel is seeking a Medical Device & Technology Associate Attorney to join a prestigious Am Law firm in Washington, D.C.

This is an exceptional opportunity for an attorney interested in FDA regulatory law and medical device regulation to join a nationally recognized Food, Drug, Medical Device & Agriculture practice. The team advises medical device, biotechnology, pharmaceutical, and digital health companies on the full lifecycle of FDA regulatory compliance, including premarket submissions, post-market obligations, enforcement matters, and emerging issues involving artificial intelligence and software-based medical technologies.

Responsibilities

• Advise clients on FDA regulatory requirements governing medical devices and related technologies.

• Counsel clients on regulatory pathways for medical devices, including 510(k) notifications, Investigational Device Exemptions (IDEs), De Novo requests, and Premarket Approval Applications (PMAs).

• Assist with FDA submissions, agency communications, and responses to deficiency letters and regulatory inquiries.

• Advise on post-market compliance matters, including quality system regulations, recalls, adverse event reporting, and FDA enforcement issues.

• Counsel clients on regulatory considerations affecting software as a medical device (SaMD), digital health technologies, artificial intelligence (AI), machine learning, cybersecurity, and diagnostic products.

• Research and analyze evolving FDA regulations and related state, federal, and international regulatory developments.

• Develop practical regulatory strategies that support innovative product development while managing compliance risks.

• Collaborate with clients and multidisciplinary legal teams on sophisticated regulatory matters throughout the product lifecycle.

Qualifications

• J.D. from an ABA-accredited law school.

• Active membership in, or eligibility for admission to, the District of Columbia Bar.

• Demonstrated interest in FDA regulatory law and medical device regulation.

• Experience with FDA medical device matters is strongly preferred.

• Experience at the FDA or within the medical device, pharmaceutical, or biotechnology industries is a plus.

• Scientific, engineering, health sciences, or biotechnology background is preferred but not required.

• Excellent legal research, analytical, drafting, and communication skills.

• Strong academic credentials and the ability to thrive in a collaborative, fast-paced, client-focused environment.

Compensation & Benefits

• Salary: $235,000-$310,000, commensurate with experience and qualifications.

• Comprehensive benefits package, including:

  • Medical, dental, and vision insurance

  • 401(k) retirement plan

  • Paid time off

  • Annual performance and discretionary bonus eligibility

  • Relocation assistance, where applicable