Senior Regulatory Consultant

This is a remote position.

Role Summary

The Senior Regulatory Consultant provides advanced regulatory expertise, strategic guidance, and independent assessment for complex regulatory, technical, and compliance matters. This resource leads activities requiring regulatory interpretation, risk-based decision-making, cross-functional coordination, and development of regulatory strategy.

Key Responsibilities

• Serve as a senior regulatory advisor for complex product, quality, submission, and compliance matters.
• Lead regulatory impact assessments associated with product, material, design, manufacturing, or process changes.
• Conduct or oversee complex assessments such as toxicological, biological, material-characterization, or regulatory risk evaluations, as applicable to the consultant's area of expertise.
• Determine the regulatory impact of changes and recommend appropriate documentation, testing, or submission pathways.
• Provide strategic oversight for the organization's Standards Management Program, including interpretation of new or revised standards and evaluation of applicability.
• Develop strategies for implementation of significant regulatory or standards changes.
• Lead or provide strategic support for U.S. and international submissions.
• Assess regulatory pathways, submission requirements, documentation gaps, and market-specific requirements.
• Lead development and remediation of Technical Documentation, including complex gap assessments and regulatory compliance strategies.
• Advise on alignment of the organization's Quality Management System with applicable regulatory and international standards.
• Perform higher-level reviews of SOPs, regulatory procedures, compliance processes, and quality documentation.
• Design or advise on compliance information management systems and regulatory governance processes.
• Interpret FDA, EU MDR/IVDR, ISO, IEC, and other applicable regulatory requirements and translate them into practical business requirements.
• Review and provide final regulatory oversight of documentation prepared by junior consultants or internal teams. Criterion Edge | Regulatory Consulting
• Participate in regulatory authority interactions and support preparation for agency or Notified Body questions, as applicable.
• Identify regulatory risks proactively and recommend mitigation strategies.
• Provide ad-hoc senior regulatory consulting based on emerging business, compliance, and product-development needs.

Typical Assignments

• Regulatory strategy development
• Complex standards applicability assessments
• Product or material change assessments
• Toxicological or biological regulatory assessments
• Regulatory pathway evaluations
• International submission strategy
• Complex Technical Documentation development or remediation
• QMS gap assessments and strategic alignment
• Regulatory authority or Notified Body preparation
• Compliance strategy development
• Regulatory risk assessments
• Oversight and review of junior regulatory work

Recommended Experience

• Approximately 8–15+ years of regulatory affairs experience within the applicable regulated industry.
• Demonstrated experience independently developing and executing regulatory strategies.
• Advanced understanding of FDA requirements, international regulations, and applicable consensus standards.
• Experience with complex Technical Documentation, regulatory submissions, QMS requirements, and regulatory change assessments.
• Ability to independently interpret regulatory requirements and provide defensible recommendations.
• Experience advising senior leadership and cross-functional technical teams.