Principal Regulatory Consultant (1099)

Lead and execute global regulatory strategies for Class II–III medical devices, biologics, and combination products. Prepare, author, and submit regulatory filings including 510(k), PMA, IDE, Technical Files, Clinical Evaluation Reports, and Q-subs. Serve as primary liaison with FDA, Notified Bodies, and other health authorities, including preparation of responses to regulatory findings. Perform Quality Engineering activities in support of regulatory objectives, including CAPA, risk management, and QMS support. Maintain and support QMS infrastructure, including establishment registration, GUDID, and compliance with 21 CFR 820/QMSR and ISO standards. Support audit and inspection readiness through direct participation and execution. Develop regulatory and quality training materials and support cross-functional teams. Serve as PRRC under EU MDR, where applicable. This role requires 15+ years of experience in Regulatory Affairs and Quality within the medical device or life sciences industry. This is a remote position.