Senior Regulatory Consultant

Criterion Edge Professional Services Inc.•Los Angeles, CA

1d•$125 - $200

About The Position

The Senior Regulatory Consultant provides advanced regulatory expertise, strategic guidance, and independent assessment for complex regulatory, technical, and compliance matters. The role leads work requiring regulatory interpretation, risk-based decision-making, cross-functional coordination, and development of regulatory strategy. The consultant advises on complex product, quality, submission, and compliance matters; assesses regulatory impacts of changes; and recommends appropriate documentation, testing, and submission pathways. The role also provides strategic oversight for the Standards Management Program, supports U.S. and international submissions, and leads development or remediation of Technical Documentation. The consultant advises on Quality Management System alignment, reviews regulatory and quality documentation, and helps design compliance information-management systems and governance processes. The role interprets FDA, EU MDR/IVDR, ISO, IEC, and other applicable requirements, provides final regulatory oversight of work prepared by junior consultants or internal teams, supports regulatory authority or Notified Body interactions, and identifies and mitigates regulatory risks. Assignments may include strategy development, complex assessments, submission planning, QMS gap assessments, compliance strategy, and review of junior regulatory work.

Requirements

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.

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 toxicological, biological, material-characterization, or regulatory risk assessments, as applicable to the consultant's expertise.
Determine regulatory impacts of changes and recommend appropriate documentation, testing, or submission pathways.
Provide strategic oversight for the Standards Management Program, including interpreting new or revised standards and evaluating applicability.
Develop strategies to implement 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.
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.