Principal Regulatory Consultant (1099)

Job Description This is a remote position. About the Role MB&A is seeking a hands-on Principal Regulatory Consultant who combines recent, real-world regulatory submission experience with practical Quality Engineering execution. This role is designed for consultants who actively prepare and submit filings, engage directly with regulatory authorities, and contribute to hands-on quality activities —not purely advisory leadership. The ideal candidate brings deep regulatory expertise and direct execution experience supporting global regulatory submissions and quality systems in regulated environments. Key Responsibilities 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 . Support EU MDR and FDA regulatory compliance activities through hands-on execution. Serve as primary liaison with FDA, Notified Bodies, and other health authorities , including preparation of responses to regulatory findings (e.g., FDA 483s). 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. Requirements Minimum Qualifications 15+ years of experience in Regulatory Affairs and Quality within the medical device or life sciences industry. Demonstrated hands-on regulatory submission experience within the last 5 years , including preparation and submission of FDA and/or EU filings. Recent hands-on Quality Engineering experience supporting QMS, CAPA, risk management, or inspection readiness. Strong working knowledge of FDA regulations, EU MDR, ISO 13485, ISO 14971 , and related global standards. Proven experience interfacing directly with FDA and Notified Bodies . Strong technical writing and regulatory communication skills . Certifications (Preferred) CQA, RAPS, or equivalent Regulatory/Quality certifications PMP (preferred) MDR and Complaint Handling Training Benefits Why Join MB&A as a Consultant? MB&A partners with experienced consultants who thrive in complex, regulated environments and bring both strategic regulatory insight and hands-on execution. Our consultants support high-impact regulatory engagements , helping clients successfully navigate global regulatory pathways while maintaining strong quality and compliance standards.