Senior Regulatory Strategist - Global Submissions (Remote)

Criterion Edge Professional Services Inc.; Los Angeles (CA); Remote; USD 120,000 - 190,000; Full time

Job summary

Criterion Edge Regulatory Consulting is seeking a Senior Regulatory Consultant for a remote role in the United States. The role provides advanced regulatory expertise, strategic guidance, and independent assessment for complex regulatory, technical, and compliance matters.

You will lead activities requiring regulatory interpretation and cross-functional coordination, and shape regulatory strategy. The position emphasizes leadership in U.S.

Qualifications

• Approximately 8–15+ years of regulatory affairs experience in the applicable regulated industry.
• Ability to independently develop and execute 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 for product, material, design, manufacturing, or process changes.
• Conduct or oversee complex assessments such as toxicological, biological, material-characterization, or regulatory risk evaluations.
• Determine the regulatory impact of changes and recommend documentation, testing, or submission pathways.
• Provide strategic oversight for the organization's Standards Management Program and interpretation of standards.
• Develop strategies for implementing 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 gap assessments and strategies.
• Advise on alignment of the organization's QMS with regulatory and international standards.
• Perform higher-level reviews of SOPs, regulatory procedures, and quality documentation.
• Design or advise on regulatory information management systems and governance processes.
• Interpret FDA, EU MDR/IVDR, ISO, IEC, and other applicable regulatory requirements and translate them into business needs.
• Review and provide final regulatory oversight of documentation prepared by junior consultants or internal teams.

Skills

Regulatory strategy

Regulatory affairs

FDA and international regs

Technical documentation

QMS & regulatory change

Leadership & cross-functional

Job description

Criterion Edge Regulatory Consulting is seeking a Senior Regulatory Consultant for a remote role in the United States. The role provides advanced regulatory expertise, strategic guidance, and independent assessment for complex regulatory, technical, and compliance matters.

You will lead activities requiring regulatory interpretation and cross-functional coordination, and shape regulatory strategy. The position emphasizes leadership in U.S.