Regulatory Affairs and Quality Systems Specialist – Remote Resume

Candidate Pitch:

To obtain a full-time remote position in Quality Assurance or Regulatory Affairs where I can leverage over 10 years of hands-on experience in FDA-regulated environments, including ISO 13485 QMS implementation, global regulatory submissions (510(k), CE Mark, ICES-003), and cross-functional compliance leadership. I bring a proven track record of audit readiness, document control, and CAPA management across Class II medical device platforms. I am currently completing the final 5 credit hours of a B.S. in Supply Chain Management and actively pursuing CQIA and RAC certifications to expand my global compliance credentials. My goal is to support a forward-thinking organization with risk-based decision-making, continuous improvement, and regulatory excellence. Quality Assurance & Regulatory Affairs Coordinator Micro Audiometrics Corp — Remote / Daytona Beach, FL November 2021 – Present Designed and implemented a full ISO 13485:2016-compliant Quality Management System (QMS) for a Class II medical device company. Led FDA audit readiness efforts—achieved zero 483 observations during multi-day inspection. Authored risk-based SOPs and internal protocols for IEC 60601-1 in-house electrical safety testing. Integrated document control, CAPA, training, and audit tracking into ERP (Odoo) and Microsoft 365 systems. Supported CE Mark and Health Canada submissions; maintained MDR-compliant technical files. Managed complaint handling, CAPA workflows, and postmarket surveillance documentation. Qualified suppliers and enforced risk-classified incoming inspection plans. Trained cross-functional teams on ISO 14971, IEC 62366-1, and document lifecycle procedures. Reduced CAPA closure time by 35% and improved supplier audit success rate by 27%. Reduced external testing costs by 70% through internal verification program using Fluke ESA612. Managing Partner / Compliance Trainer Red Robin Gourmet Burgers — Huntsville, AL June 2014 – November 2021 Led a $4M/year operation with 60+ team members; managed SOP compliance and training programs. Trained Assistant General Managers across TN and GA on QA, labor law, and documentation protocols. Implemented process corrections that led to a 10% YoY revenue increase and reduced operational risk. Managed scheduling, performance tracking, and policy audits using ERP and workforce software. Standardized workflows and documentation in alignment with corporate and regulatory requirements. University of Alabama in Huntsville (UAH) B.S. in Supply Chain Management – In Progress Expected Graduation: December 2025 Currently completing final 5 credit hours on a part-time basis Does not interfere with full-time remote work availability University of Tennessee, Knoxville – Haslam College of Business Attended: 2015 – 2017 Affiliations & Certifications Council for Six Sigma Certification (CSSC) – White Belt Certified | Yellow Belt In Progress American Society for Quality (ASQ) – Member | CQIA (Certified Quality Improvement Associate) In Progress Regulatory Affairs Professionals Society (RAPS) – Member | RAC (Global) Candidate ProHIPAA / HIPAA for Professionals – Certified (2025) Regulatory Compliance & Quality Systems FDA 21 CFR Part 820 (QSR), Part 803, Part 806, Part 807 Compliance ISO 13485:2016 QMS Design, Implementation, and Audit Readiness ISO 9001 ISO 14001 EU MDR 2017/745 & Health Canada Documentation Support Technical File Preparation for CE Mark / Global Submissions Risk Management per ISO 14971 Usability Engineering per IEC 62366-1 Electrical Safety & EMC Compliance: IEC 60601-1, 60601-1-2, IEC 60645-1 Complaint Handling & Postmarket Surveillance Systems CAPA Management, Root Cause Analysis, and Effectiveness Verification Nonconforming Product Management and SCAR Implementation UDI & Labeling Compliance, IFU Validation and Localization FDA 510(k) Documentation Support & eCTD/CTD Formatting Document Control (SOP Lifecycle, Version Control, Approval Traceability) Internal Audit Execution, Audit Trail Reviews, and Regulatory Hosting Clinical Systems Audit Preparedness (GCP, ICH E6 R2 – In Progress) HIPAA Privacy Implementation & Workforce Training Process Improvement & Workflow Automation Lean Documentation Workflows & Continuous Improvement Strategy QMS Process Mapping & SOP Acknowledgment Tracking CAPA Automation & Risk-Based Escalation Tiers Training Program Automation & Dashboard Reporting Closed-Loop Quality Systems Integrated into ERP Platforms Supplier Qualification & Risk Classification Framework Quality Agreements, Incoming Inspection Criteria, and Ongoing Evaluation Process Validation Support (IQ, OQ, PQ Alignment) Quality Metrics Reporting (CAPA Cycle Times, Supplier Performance, Audit Findings) Systems & Technology ERP Systems: Odoo, SAP, NetSuite QMS/Compliance Platforms: Greenlight Guru, MasterControl, TrackWise, Qualio Microsoft 365: SharePoint, Outlook, Teams, Excel Automation Document Workflow: Adobe Sign, DocuSign, Smartsheet, NAVEX Communication & Collaboration: Zoom, Slack, Confluence, Jira PLM & CRM Tools (General Platform Experience) Biomedical Analyzers: Fluke ESA612, Dale 601 for Electrical Safety Testing Power BI (Quality Metrics Visualization), Google Workspace Certifications & Memberships Six Sigma White Belt – CSSC | Green Belt In Progress CQIA – ASQ (In Progress) RAC (Global) – RAPS (Planned) HIPAA for Professionals – Certified (ProHIPAA) ICH-GCP – In Progress (FDA/NIH) Greenlight Guru – ISO 13485 & Design Controls Training FDA ORA-U Regulatory Compliance Training Soft Skills & Remote Strengths Cross-Functional Leadership in Remote and Hybrid Teams High Attention to Detail & Document Accuracy Strong Verbal and Written Regulatory Communication Self-Directed, Deadline-Driven, and Risk-Conscious Effective in Hosting Inspections and Leading Internal Audits Remote Collaboration Across Regulatory, Engineering, and Operations Teams Fully remote-ready with established home office setup, including secure data access, video conferencing, and document collaboration tools (Microsoft 365, Teams, Zoom). Currently completing final 5 credit hours of B.S. in Supply Chain Management at the University of Alabama in Huntsville; coursework does not interfere with full-time work availability. Actively pursuing RAC (Global) and CQIA certifications to expand global regulatory and quality systems expertise. Available for full-time remote opportunities across U.S. time zones with flexible scheduling to accommodate global teams. Proven success in FDA inspections (zero 483s), ISO audits, CE Mark documentation, and integrated ERP-QMS platforms. References available upon request.