Senior Regulatory Consultant

This is a remote position.

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.

• 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.

• 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

• 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.