Principal Regulatory Consultant (1099)

This is a remote position.

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.

• 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

• 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.
  

Benefits

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.