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
