Edgewater, MD30+ days ago
The Principal Consultant supports U.S. regulatory programs across the full product lifecycle-including early development, clinical investigations, marketing applications, and post-market activities-and collaborates with sponsor leadership to shape regulatory strategy, support FDA interactions, and expand client relationships. Our team includes former FDA reviewers, engineers, clinicians, scientists, and regulatory strategists with extensive experience supporting Class II and Class III medical devices, including Pre-Submissions, IDEs, 510(k)s, PMAs, HDEs, and post-market programs.