• Own RMF authorizations across Department of War components and FedRAMP High, alongside CMMC 2.0 and SOC 2 compliance for corporate systems • Maintain authorization and audit evidence, including SSPs, SARs, POA&Ms, STIGs, and control mappings • Partner with Engineering, Product, and Security to embed compliance requirements into system design and CI/CD workflows, not bolt them on afterward • Coordinate internal assessments and external audit readiness across all applicable frameworks • Track regulatory and contractual changes and advise leadership on what they mean for Onebrief • Run risk assessments and vendor/supply chain risk reviews across both federal and corporate environments

• Maintain and improve the QMS. • Manage controlled documents, policies, procedures, templates, and SOPs. • Coordinate document reviews, version control, approvals, and updates. • Track corrective and preventive actions (CAPA). • Support PMO governance and process standardization. • Support CMMI, CMMC, ISO 9001, ISO 20000, ISO 27001, and customer-required frameworks. • Maintain evidence repositories and compliance documentation. • Coordinate evidence collection and audit readiness. • Track remediation actions and gap assessments. • Monitor contract deliverables and reporting requirements. • Maintain compliance calendars and milestones. • Support startup, transition, and closeout activities. • Review contract requirements for operational impacts. • Track SLA, KPI, and Quality Control Plan compliance. • Plan and coordinate internal audits. • Support external certification audits. • Track findings through closure. • Prepare audit reports and executive summaries. • Review project documentation for quality and completeness. • Support governance reviews and project health assessments. • Maintain PMO templates and standards. • Capture lessons learned and improvement opportunities. • Develop dashboards for compliance, audits, certifications, contract performance, and PMO maturity. • Provide monthly executive reporting. • Maintain centralized compliance repositories. • Support document retention requirements. • Keep templates and policies current.

• Lead efforts to ensure regulatory compliance and manage compliance risk within the organization • Immerse yourself in the company’s operations and develop robust compliance frameworks • Collaborate closely with various teams to implement effective compliance programs • Conduct regular audits and provide guidance on regulatory requirements • Foster a culture of integrity and accountability, ensuring business practices uphold the highest ethical standards • Coordinate, process, and monitor license obligations for established and newly regulated igaming markets • Communicate effectively and develop strong relationships with regulatory authorities for approvals • Work closely with key stakeholders internally and externally in the regulatory landscape • Stay up to date with regulatory developments and best practices in compliance control • Identify, document, and increase efficiencies of business processes to align with compliance requirements • Develop project plans, reports, and schedules for relevant stakeholders and teams

• The Director, CDx Regulatory Consultant will be responsible for applying deep expertise in companion diagnostic regulatory strategy, IVD development, quality system expectations, and global marketing authorization pathways to advise pharmaceutical, biotechnology, and diagnostic clients on the development, clinical trial use, approval, and lifecycle management of companion diagnostics. • Translate complex FDA, EU IVDR, and other global regulatory requirements into practical, actionable strategies that support Rx Dx co-development, patient selection assays, analytical and clinical validation planning, clinical trial enabling submissions, and coordinated diagnostic and therapeutic commercialization. • Serve as the CDx regulatory subject matter expert for strategic positioning of client programs. • Proactively identify client needs by understanding the therapeutic program, biomarker strategy, intended use population, assay technology, clinical trial design, and commercial objectives. • Lead consulting engagements with pharmaceutical clients to develop global CDx regulatory strategies, integrated development roadmaps, submission pathways, and milestone-based timelines that support clinical trial execution, regulatory authorization, and commercialization objectives. • Partner cross-functionally with therapeutic development teams, diagnostic manufacturers, laboratories, biostatistics, clinical operations, quality assurance, and commercial stakeholders to ensure CDx development activities are coordinated with overall program timelines and regulatory expectations.