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✅ 14+ years of Experience ✅ ISO Consultant (9001:2015/27001:2022/FSSC/FDA/UL-94-181/Food/HACCP/CCP/PRP's) ✅ Proven Results in ISO 9001, 27001, 14001, 45001, 22000, FSSC, SQF, 14064, 14065, 21001, 42001, ISO 51001:2024 ✅ISO 13485 and MDSAP-aligned Medical Device QMS readiness ✅ ISO AS9100D, EN9120 Specialist ✅ SOC 2 and CMMC Specialist ✅ CCPA/CPRA Compliance Specialist (Opt-Out Mechanisms, Data Sharing/Selling Controls) ✅ Legal and Regulatory Copywriter for Packaging Compliance ✅ Certified Quality Professional ✅ Secure SDLC & Privacy-by-Design Implementation ✅ ISO 14064-14065 Greenhouse Gas Emission (Certification & Accreditation) ✅ ISO 14064-1,14064-2,14064-3 (Verification and Validation) ✅ SAP S4/HANA QM Certified ✅ SQFI Implementation Expert ✅ Sustainability Data Management ✅ Internal Audit Expert ✅ Policy Writing ✅ SOP Specialist ✅ Company Policies and Procedures Manual ✅ Work Instruction & Checklist Draft Specialist ✅ FDA Regulations (Food, BRC, REACH, RoH) ✅ Data Visualization Expert ✅ Process Optimization Pro ✅ Process Mapping ✅ Document Control ✅ Manufacturing Data Specialist ✅ Virtual Assistance ✅ Operations & Process Structuring Consultant ⚡ Comprehensive Auditing: In-depth audits for ISO 9001 (Quality Management Systems) and ISO 27001 (Information Security Management Systems), ensuring compliance and identifying areas for improvement. ⚡ Customized Solutions: Tailored advice and strategies to meet your specific organizational needs, while aligning with international standards. ⚡ Continuous Improvement: Guidance on implementing best practices for ongoing quality and security enhancements. ⚡ Risk Management: Expert analysis and recommendations to mitigate risks, ensuring robust and resilient systems. ⚡ Training and Support: Providing staff training and support to understand and effectively implement ISO standards. 🚀Specialized Expertise🚀 in Quality Control, Assurance, and Audit Management across diverse sectors including manufacturing, healthcare, food, petrochemical, and automotive industries, I have consistently demonstrated leadership in achieving ISO 9001, BRC, ISO 27001, and ISO 14001 certifications. My proficiency extends to Data Visualization, where I leverage advanced techniques to drive insights and informed decision-making. In addition to my certification leadership, I have successfully spearheaded process safety initiatives and optimized business processes. My adeptness in SAP implementation and Quality Management (QM) ensures seamless operations and adherence to best practices. Furthermore, I possess a strong track record in complaint handling and process optimization. As an ISO Consultant and Writer, I am dedicated to crafting meticulous Policy & Procedure Documentation aligned with ISO standards, while ensuring full compliance with GDPR requirements. My commitment to excellence is evident in my punctual delivery and relentless pursuit of customer satisfaction, reinforced by consistently positive client feedback. In all my endeavors, I priorities not only quality and efficiency but also the safeguarding of data protection and privacy, thereby fostering trust and confidence in every project undertaken.

I’m a fintech Risk & Compliance professional with experience across leading regulated organisations including Revolut, Deloitte, EY and Santander. I have received 5 star client feedback for FCA compliance and regulatory consulting engagements, with clients highlighting my professionalism, communication and practical, risk based approach. I specialise in helping fintechs and growing businesses design, implement and strengthen risk and compliance frameworks in a practical and proportionate way, enabling organisations to meet regulatory expectations without unnecessary complexity. My experience includes: • Building risk and compliance frameworks from the ground up • Designing and implementing compliance monitoring programmes • Supporting FCA and regulatory alignment across multiple jurisdictions • Advising on conduct risk, Consumer Duty and customer outcomes • Developing risk reporting, KRIs and governance structures • Third-party risk management and supplier oversight • Data protection and GDPR (CIPP/E qualified) • Internal audit, control reviews and audit readiness activities • Policy development, governance frameworks and regulatory documentation I take a pragmatic, business focused approach, identifying key risks quickly and providing clear, actionable recommendations that support compliance while enabling business growth. If you need support with a compliance review, risk framework, governance programme, GDPR compliance or regulatory readiness initiative, I would be happy to help.

Healthcare Compliance & Privacy Officer | Founder, Brivara Consulting LLC | Building Practical Compliance Programs That Work I am a healthcare compliance consultant and founder of Brivara Consulting LLC. I partner with healthcare organizations to make compliance and privacy programs functional, not just paper-based. With 10+ years leading compliance programs across multi-state healthcare environments, I focus on identifying process, documentation, and workflow breakdowns, then building practical solutions aligned with regulatory requirements. My Background: Corporate Compliance Manager & Privacy Officer for multi-state TPA, where I: *Rebuilt enterprise HIPAA privacy program, reducing violation risk 65% and achieving zero-penalty outcome during OCR review *Led audit and monitoring programs identifying compliance gaps across billing, operations, and documentation workflows *Directed CMS regulatory reporting (RxDC, HCRA) with 100% accuracy, eliminating penalties *Managed privacy incident response and investigation activities *Led multi-state licensing strategy post-merger, reducing approval timelines and eliminating denials Operations & Compliance Manager for multi-specialty gastroenterology practice, where I: *Implemented HealthStream HIPAA platform, achieving 100% completion (up from <80%) *Ensured 100% on-time compliance with HIPAA, OSHA, and payer reporting deadlines *Standardized scheduling, referrals, and documentation workflows across rotating provider teams Patient Care Services Supervisor for anesthesia billing services, where I: *Maintained 87%+ coding accuracy rate for CPT, ICD-10, and ASA coding *Led audits and quality assurance ensuring Medicare compliance *Supervised credentialing and accounts resolution Certifications: Certified HIPAA Compliance Officer (CHCO) Officer of Healthcare Corporate Compliance (OHCC) Certified Professional Coder (CPC) Certified Healthcare Collections Manager (CHCM) CIPP (in progress) What I Do for Clients: - HIPAA Privacy & Security Program Reviews: Assess current state, identify gaps, provide remediation roadmap - Audit Preparation & Compliance Gap Assessments: Evaluate documentation, workflows, and policies against regulatory standards - Policy & SOP Development: Create compliance frameworks aligned to real operational workflows, not just templates - Medicare & Billing Compliance Review: Assess Part B billing practices, documentation requirements, and reimbursement processes - Workflow & Process Alignment: Review operational processes to identify and reduce compliance risk - Privacy Officer Services: Incident response, breach management, risk assessments, and privacy program oversight - Multi-State Licensing & Regulatory Support: Navigate state-specific requirements for expanding operations - Documentation & Reporting Improvements: Strengthen audit defensibility and regulatory reporting accuracy Who I Work With: I'm best suited for small to mid-size healthcare organizations, medical practices, TPAs, health tech startups, medical spas, mobile diagnostic services, and healthcare service providers who need compliance expertise but don't require a full-time director. I work with: *Companies preparing for audits or accreditation *Organizations launching new services or entering new markets *Practices that had compliance incidents and need remediation *Startups building compliance programs from scratch *Multi-state operations needing regulatory alignment *Mobile healthcare services (imaging, home health, ancillary services) *Aesthetic medicine and medical spa operations *Telehealth and digital health platforms My Approach: I don't just provide recommendations; I help implement solutions that work in practice. I communicate complex regulatory requirements in plain language, partner cross-functionally with operational teams, and focus on sustainable compliance that aligns with how your business actually operates. Regulatory Expertise: HIPAA, HITECH, CMS, Medicare Part B, OCR, FWA, AKS, Stark Law, OSHA, ERISA, NCQA, State Licensing, Arizona DHS, Multi-State TPA Regulations Technical Knowledge: CPT, ICD-10-CM, ASA Coding, NCCI, Medical Billing & Reimbursement, Utilization Management, Claims Processing, NPPES/NPI Management Available for project-based, fractional, or ongoing contract work. Founder of Brivara Consulting LLC. Based in Charlotte, NC (with multi-state market familiarity). Quick turnaround times and responsive communication.

I bring a diverse background in internal auditing and administrative operations across manufacturing, trading, aviation, education, and health sectors. With a strong track record of delivering internal audits aligned with international standards, I help clients achieve and maintain compliance while improving their operational efficiency and risk posture. Certifications: ✅ ISO 9001:2015 Quality Management Systems Lead Auditor Exemplar Global Competency Units: TL, AU, QM Issued by Global Compliance Certification (GCC) ✅ Operational Hazard Identification and Risk Mitigation Course Issued by Singapore Aviation Academy, International Civil Aviation Regulation (ICAO) Course Code: 201/146/SMS HIRM | May 7–10, 2018 ✅ Core Competencies -Internal Auditing & Compliance (ISO 9001, ISO 14001, NDIS, SMS, Civil Aviation Regulation, EduTrust) -Risk Management -Policy & Procedure Development -Templates and Forms Creation -Documentation & Audit Preparation ✅ SOFT SKILLS ✓ Results-oriented ✓ Deliver projects as planned ✓ Organize ✓ Fast learner ✓ Resourceful ✓ Determined ✓ Can work with less supervision ✅ TECHNICAL SKILLS: 1. In-depth knowledge of: - Quality Management System (ISO 9001) - Safety Management System (SMS, ICAO) - Environmental Management System (ISO 14001) - National Disability Insurance Scheme (NDIS, Australia) - Philippine Civil Aviation Regulations - EduTrust (Singapore) Can develop documents such as but not limited to the following: a. Manuals - Quality Management System Manual - Safety Management System Manual (Safety Policy and Objectives, Safety Risk Management, Safety Assurance and Safety Promotion) - Basic Operating Manual b. Policies and Procedures - Corporate Governance and Strategic Planning - Recruitment and Deployment - Employee Training and Development - Business Travel and Expense - Procurement of Goods and Services - Supplier Accreditation and Qualification - Internal Audit Management - Document and Records Management - Auditors Evaluation - Continual Improvement - Safety Incident and Accident Reporting - Hazard Identification and Risk Assessment c. Forms/Templates/Checklists - Attendance Sheet - SL/VL - Liquidation - Reimbursement - Inventory Sheet - Purchase Request - Delivery Receipt - Purchase Order - Invoice - Employee Personal Data - Incident/Accident Report - Hazard Identification Report - Hazard Assessment - Corrective and Preventive Action - Audit Notification - Audit Yearly Schedule - Audit Checklist 2. In-depth knowledge of MS Office Word, Excel, and PowerPoint 3. Can convert MS Office files to PDF or vice-versa 4. Knowledgeable in the use of Google Apps such as Google Drive, Calendar, Meet, Maps, Gmail, Docs, Sheets, and Forms) 5. Knowledgeable in the use of Canva (editing and posting it on Social Media) 6. Email Management (Outlook, Gmail, Yahoo) 7. Knowledgeable on the use of project management software (Click-up, Asana, Mondaycom, Hubspot, Sweet Process, CRM, Podio)

𝗚𝗢𝗩𝗘𝗥𝗡𝗠𝗘𝗡𝗧 𝗖𝗢𝗡𝗧𝗥𝗔𝗖𝗧𝗜𝗡𝗚 𝗜𝗦 𝗡𝗢𝗧 𝗔𝗕𝗢𝗨𝗧 𝗟𝗨𝗖𝗞, 𝗜𝗧’𝗦 𝗔𝗕𝗢𝗨𝗧 𝗦𝗧𝗥𝗔𝗧𝗘𝗚𝗬, 𝗖𝗢𝗠𝗣𝗟𝗜𝗔𝗡𝗖𝗘, 𝗔𝗡𝗗 𝗘𝗫𝗘𝗖𝗨𝗧𝗜𝗢𝗡. Winning government contracts requires more than simply submitting a proposal. It demands a deep understanding of solicitation requirements, compliance standards, evaluation criteria, and procurement processes. A single oversight can cost a business a valuable contract opportunity. I help businesses, contractors, and organizations successfully compete for Federal, State, Local, and Commercial contracts by providing expert proposal development, solicitation analysis, bid strategy, and compliance support. As a Government Contract Proposal Specialist, I assist clients in transforming complex RFPs, RFQs, IFBs, Sources Sought Notices, and Government Tenders into professionally structured, compliant, and competitive submissions designed to maximize their chances of award. My goal is simple: Help your business submit stronger proposals, avoid costly compliance mistakes, and compete with confidence. 𝗠𝗬 𝗦𝗘𝗥𝗩𝗜𝗖𝗘𝗦 ✔ Government Contract Proposal Writing ✔ RFP, RFQ, IFB & Tender Response Development ✔ Solicitation Analysis & Requirement Breakdown ✔ Capability Statement Design & Development ✔ SAM.gov Contract Opportunity Research ✔ Federal, State & Local Procurement Consulting ✔ Compliance Review & Evaluation Criteria Analysis ✔ NAICS Code & PSC Code Research ✔ Bid/No-Bid Decision Support ✔ Sources Sought & Market Research Responses ✔ Subcontracting Opportunity Research ✔ Proposal Management & Submission Readiness Reviews ✔ Scope of Work Analysis ✔ Procurement Strategy Development ✔ Small Business Government Contracting Guidance 𝗪𝗛𝗬 𝗖𝗟𝗜𝗘𝗡𝗧𝗦 𝗛𝗜𝗥𝗘 𝗠𝗘 Government agencies evaluate proposals based on strict requirements, compliance, responsiveness, and overall value. Many businesses lose opportunities not because they lack qualifications, but because their submissions fail to address critical requirements. I help clients reduce that risk by ensuring proposals are: • Fully compliant with solicitation requirements • Professionally structured and easy to evaluate • Aligned with evaluation factors and scoring criteria • Strategically organized to highlight strengths • Thoroughly reviewed before submission My work focuses on accuracy, attention to detail, compliance, and competitive positioning—key factors that influence procurement decisions. 𝗜𝗡𝗗𝗨𝗦𝗧𝗥𝗜𝗘𝗦 𝗜 𝗦𝗨𝗣𝗣𝗢𝗥𝗧 • Construction & General Contracting • Facility Support Services • Janitorial & Maintenance Services • Information Technology (IT) • Cybersecurity & Professional Services • Logistics & Transportation • Healthcare Support Services • Engineering Services • Consulting & Business Services • Staffing & Workforce Solutions • Manufacturing & Supply Contracts • Small Business & Subcontracting Opportunities 𝗠𝗬 𝗣𝗥𝗢𝗖𝗘𝗦𝗦 1. Thorough solicitation review and analysis 2. Identification of mandatory requirements and evaluation criteria 3. Compliance mapping and response planning 4. Proposal strategy development 5. Proposal writing and content organization 6. Quality assurance and compliance review 7. Final submission readiness assessment Whether you're pursuing your first government contract or expanding an established contracting portfolio, I can help you navigate the procurement process and strengthen your competitive position. If you're serious about winning government contracts, let's work together to develop proposals that are compliant, compelling, and strategically positioned for success. 📩 Send me a message today, and let's discuss your next contracting opportunity. Government Contracting, Government Contracts, Federal Contracts, Government Procurement, Proposal Writing, Government Proposal Writer, RFP Writing, RFQ Response, IFB Response, Tender Writing, Bid Proposal Writing, Proposal Development, Proposal Management, Bid Management, Procurement Consulting, Contract Research, Solicitation Analysis, Compliance Review, Compliance Matrix, Capability Statement, SAM.gov, Sources Sought Response, Market Research, Contract Opportunity Research, Procurement Strategy, Government Bidding, Federal Acquisition, NAICS Research, PSC Code Research, Scope of Work Analysis, Evaluation Criteria Analysis, Technical Proposal Writing, Proposal Review, Proposal Editing, Capture Management, Contract Compliance, Subcontracting Opportunities, Small Business Government Contracts, Business Development, Public Procurement, Contract Specialist, Government Bid Consultant, Procurement Analysis, Bid Strategy, Contract Opportunity Identification, Vendor Registration, Government Sales, Federal Proposal Writer, Government Tender Specialist, Proposal Consultant.

Unleash AI. Keep the leash. I write policies and procedures, build compliance frameworks, and develop AI-powered products for companies in regulated industries. GDPR. HIPAA. ISO 9001. ISO 27001. FDA 21 CFR Part 11. When AI enters the picture I layer in governance frameworks, privacy policies, & purpose-built agents trained on domain knowledge - not generic demos. 27 years in regulated industries. 300+ templates. 75-90% faster than traditional consulting using my trademarked AAIG methodology. I am not a consultant who says "no." I find the "yes, if we do it this way" path that lets you move fast and stay compliant. WHAT I BUILD Policies, Procedures, & Quality Management. SOPs, quality manuals, work instructions, and complete QMS builds. ISO 9001/27001/42001 from gap assessment through certification readiness. Audit preparation, corrective action workflows, and management review packages. Rebuilt an entire QMS for a global clinical trials platform - zero audit findings. Privacy Policies, Terms of Service, and Legal Compliance Documents. GDPR-compliant privacy policies, terms of service, cookie policies, data processing agreements, sub-processor agreements, consent frameworks, and data subject rights implementation. Fixed 7 live GDPR violations for an AI meeting platform. Built Django deletion workflows for right-to-erasure compliance. Global consent matrices covering US, EU, Canada, and Asia-Pacific. AI Compliance and Risk Frameworks. EU AI Act roadmaps. ISO 42001. NIST AI RMF. HIPAA Security Risk Analyses. Privacy impact assessments for GDPR, CCPA, and Colorado AI Act. GxP validation and 21 CFR Part 11 compliance for healthcare AI. Built Resilience AI Suite for a commercial client serving business continuity and IT disaster recovery professionals at U.S. financial institutions. Each agent follows a proprietary 9-section architecture with 32+ regulatory frameworks, SR 11-7 status assessments, and quality gates averaging 73 to 121 checkboxes per agent. Prompt sizes ranged from 79,000 . AI-Powered Product Development. Built a complete business operating system for REMVER Consulting - 230+ deliverables across 10 domains. First-to-market AI Disruption Readiness Toolkit for BC/ITDR professionals. Enterprise Document Drafter Agent Suite replacing $50K-$500K/year BC software platforms. Datasheets, implementation guides, landing pages, and full sales funnel architecture. Content, Courses, & Books. 48,000-word KDP reference book. 12 Udemy courses with slide decks and speaker notes. Synthesia video content. Two published books on AI governance. Full enablement ecosystem, not just the framework. National Government AI Governance Frameworks. Developed the AI Governance Framework for the Republic of Liberia integrating NIST AI RMF, OECD, UNESCO, EU AI Act, and African Union standards. Training packages, implementation roadmaps, and stakeholder consultation for national deployment. RECENT CLIENT WORK REMVER Consulting - Complete business operating system, AI products, book, courses, GoHighLevel bots, Synthesia videos. Financial services operational resilience aligned with OCC, FDIC, FRB, FFIEC. Clineca - Full compliance architecture for AI-powered clinical trials EDC platform. EU AI Act, ISO 42001, HIPAA, GDPR, GxP. Delivered 75% faster than Big 4. Invite Ellie - GDPR/privacy framework for AI meeting assistant. Privacy policy audit (7 corrections), Django deletion workflows, Visual Capture Compliance Framework. Liberia Telecommunications Authority - National AI governance framework for government deployment. EU AI Act Startup Toolkit - Turnkey compliance toolkit on 48-hour turnaround with automated risk scoring (83 formulas). THE FOUNDATION 27 years in regulated industries. Fortune 500: Alcon/Novartis (8 years, 200+ projects), Gilead, Genzyme, Pfizer, Baxter. Zero audit findings. Consent decree and FDA regulatory action leadership. MS Operations and Project Management. PMP certified 20 years. Contributing author, The FDA Group Newsletter (10,000+ executives). Published author of two books on AI governance. 300+ templates covering EU AI Act, ISO 42001, NIST AI RMF, ISO 27001, GDPR, CCPA, HIPAA, FDA 21 CFR Part 11, and Colorado AI Act. Every template refined through Fortune 500 implementations and delivered through 10-20+ iterations before handoff. WHO HIRES ME Companies needing SOPs, quality manuals, or ISO 9001/27001 implementation. AI startups needing privacy policies or compliance frameworks to launch. SaaS companies adding AI features needing GDPR, HIPAA, or EU AI Act compliance. Healthcare and clinical trials companies deploying AI. Financial services firms needing operational resilience tools. Companies that want AI agents or chatbots built with domain expertise baked in. Anyone needing enterprise-grade compliance without enterprise timelines or budgets. Engagement: Project-based consulting, fractional leadership, AI agent development, privacy & compliance documents, framework implementation. Global/Remote.