Towanda Lorenz

Strategic and results-driven Senior Regulatory Affairs Manager with 10+ years of success in leading global regulatory submissions and post-market compliance for Class I–III medical devices, including SaMD and implantables. Expert in FDA, EU MDR, LATAM, and Health Canada regulatory frameworks. Proven ability to manage internal audits, CAPA systems, technical documentation, and cross-functional collaboration.

Known for implementing systems that accelerate speed-to-market, ensure audit-readiness, and mitigate compliance risks across diverse product portfolios.

Managing Partner at SheAlpha Studio, LLC (d/b/a SheAlpha QA/RA Consulting) (2025-05 – Present)

SheAlpha QA/RA Consulting provides Regulatory Affairs and Quality Assurance consulting for start-up medical device, biotech, and healthcare technology companies. The firm assists clients in achieving compliance with FDA 21 CFR 820, ISO 13485:2016, ISO 14971, and EU MDR 2017/745. Operations are 100% remote, offering regulatory strategy, documentation, audit, and CAPA management globally.

Mission: Empower innovators through ethical, structured, and compliance solutions, ensuring safe and effective medical devices reach the market confidently.

Vision: To be a leading woman owned-veteran-owned global consultancy for ISO 13485 and FDA QSR compliance, recognized for precision, integrity, and quality mentorship.

• Regulatory Strategy & Submissions – FDA 510(k), EU MDR Technical Files, and labeling compliance.
• Quality Management Systems – Implementation, maintenance, and internal/supplier audits for ISO 13485 certification.
• Risk & CAPA Management – Root cause analysis, CAPA effectiveness, and ISO 14971 risk assessment.
• Documentation Development – SOPs, Work Instructions, Device Master Records, and training templates.
• Post-Market Surveillance – Complaint trending, and PSUR preparation.
• Training & Audit Support – Virtual QMS training and mock inspections for audit readiness.

Quality Assurance Regulatory Affairs Manager at Oakworks, Inc. (2023-11 – 2025-05)

• Led global regulatory submissions for FDA (Class II), Health Canada (Class I & II), and EU MDR-compliant devices.
• Served as SME during design reviews, audits, and post-market surveillance.
• Regulatory Team Leadership, Mentorship & Training for team members and Senior Leadership
• Directed BSI audits and served as FDA inspection scribe and compliance coordinator.
• Managed CAPA lifecycle via QT9 ERP System, CAPA Coordinator, and conducted ISO 13485 internal audits.
• Ensured document control version and update activities for SOP's
• Managed Annual Device Listings and Registrations, UDI/GUDID listings, and labeling compliance.
• Interviewed, onboarded, and trained new team members in QA/RA roles and ISO, cGMP, GDP, and ERP Systems.
• Oversaw SharePoint-based regulatory content and company wide communications.
• Participated with Regulatory Strategy for Market Expansion & Labeling Compliance
• Practiced negotiation and communication skills working with in-country representation, suppliers, and distributors
• Cleared and resolved issues (3) with product stuck in customs.
• Handled CE Marking, PFAS, DOC, legalizations, authentications and translations of documents
• Reviewed contracts and agreements and handled product updates with EMERGO UL
• Managed budget designated for all Regulatory Activities for the FY.
• Managed the records room and all required documentation
• Maintained current employee training records
• RoHS (Restriction of Hazardous Substances Directive), REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), California Proposition 65, FDA 21 CFR Part 820 / QSR, IEC 60601 / IEC 62304 / IEC 62366 (Medical Device Electrical Standards), LVD, EMC
• PRRC for EUDAMED Database

EU MDR Regulatory Affairs Consultant at Zimmer Biomet (via Apex Systems) (2022-01 – 2023-01)

• Led remediation of technical files for EU MDR Class II/III devices including implantables, instruments, and sterile products.
• Authored PSURs and mentored new RA specialists on MDD-MDR compliance
• Managed NB inquiries and maintained on-time DOC's and CE mark renewals.
• GSPR, CER, Bookmarking, cross documentation reviews and gap analysis.

International Regulatory Affairs Specialist at Carestream Health, Inc. (2018-08 – 2021-12)

• Oversaw global market registrations across FDA, LATAM, Health Canada, and EU regions.
• Developed compliance strategies to expedite new product approvals and address CAPA issues.
• Created a database that managed product registration due dates, renewals, country requirements and created country profiles for commercialization activities
• Interfaced with BSI, DEKRA, and TUV to maintain regulatory approvals for radiological and diagnostic devices.
• Managed successfully documentation transfer during partial business acquisition
• Collaborated with third party vendors and companies such as Baxter, Medline, Johnson & Johnson
• Worked cross functionally with Senior Management, Leadership, Product and Project Management teams, R&D, Design Engineer, Distributors, and Suppliers
• Assisted with the compilation of (2) 510(k) submissions
• RoHS (Restriction of Hazardous Substances Directive), REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), California Proposition 65, FDA 21 CFR Part 820 / QSR, IEC 60601 / IEC 62304 / IEC 62366 (Medical Device Electrical Standards), LVD, EMC
• Maintained Health CANADA Amendments and licence management
• Trusted with both company credit that exceeded amounts of $80,000.00 and travel company card maintained at $25,000.00; expense reporting

Bachelor of Science in Legal Studies – South University, Savannah, GA

Associate of Science in Paralegal Studies – South University, Savannah, GA