Senior Quality Regulatory Engineer & QMS Remediation

Nicole Gamble

Lawrenceville, GA 484-***-**** **************@*****.***

Senior Quality Regulatory Engineer Validation, QMS & CAPA Remediation

TARGET ROLE

Sr Quality Engineer- ACT Arthrex

PROFESSIONAL SUMMARY

Senior Quality Regulatory Engineer with medical device quality experience in validation, OQ/PQ/TMV support, QMS remediation, CAPA, risk management, change control, audit readiness, root-cause investigations, and cross-functional quality engineering. Strong fit for contract environments needing senior quality support across commercial medical device products and remediation-driven deliverables.

REMEDIATION IMPACT

Improved validation and quality-system readiness by supporting test-method validation, procedural validation, software validation, process qualification, design verification, stability protocols, and operational qualification documentation.

Reduced remediation backlog risk by conducting CAPA, NCR, deviation, raw-material, complaint, supplier, trend, and root-cause investigations across quality engineering and regulatory environments.

Supported commercial medical device compliance by reviewing QMS records, DHF/DHR evidence, change-control packages, risk files, audit documentation, and cross-functional corrective-action plans.

PROFESSIONAL EXPERIENCE

Wellysis Senior Regulatory Lead

Oct 2025 - Jan 2026 Seoul, South Korea / Contract

Improved Notified Body readiness by coordinating MDR-compliant updates to Technical Documentation, PMS plans, PMCF documentation, PSURs, and regulatory response packages.

Protected lifecycle compliance for software-enabled devices by assessing software updates, patches, bug fixes, version releases, cybersecurity impact, and potential 510(k) notification needs.

Strengthened DHF and software technical documentation by reviewing validation, verification, usability engineering, IEC 62304, ISO 14971, and cybersecurity evidence with software teams.

Reviewed and remediated 510(k) submission packages for completeness, consistency, and alignment with FDA expectations, internal quality procedures, ISO 13485, ISO 14971, and 21 CFR requirements.

Supported 510(k) renewals and remediation activities by updating technical documentation, risk management files, labeling, biocompatibility sections, verification/validation summaries, and change assessments.

Wrote and edited regulatory submission sections including device description, indications for use, substantial equivalence discussion, performance testing summaries, software documentation, sterilization/biocompatibility summaries, labeling, and risk management rationale.

Medtronic / Redbock Staffing Senior Regulatory Lead

Sep 2022 - Aug 2025 Boulder, CO / Contract

Advanced MDR remediation work for diabetes, electrosurgical, generator, electrode, and defibrillator products by creating GSPR, STED, IFU, technical documentation, and risk-management updates for TUV and BSI review.

Reduced regulatory change risk by coordinating change orders, regulatory assessments, CFR 21 compliance reviews, DFMEA/design traceability reviews, usability report updates, and international renewal certificates.

Supported patient-safety compliance by evaluating adverse events, incidents, near misses, seriousness, expectedness, and user impact; prepared vigilance reports within required regulatory timelines.

Leading Design and development for NPD’s, coordinating quotes and procurement of new equipment with vendors, validation, work instruction development, BOM, and router management, and training of operations.

Improved quality-system audit readiness by participating in ISO 13485 and ISO 14971 recertification work and documenting essential requirements for TUV audits and Health Canada submissions.

Zoll Medical / Black Diamond Staffing Senior Regulatory Specialist III

Sep 2022 - Feb 2023 Roseville, MN / Contract

Delivered EU MDR technical-file remediation for external handles, electrodes, and defibrillator products by reviewing risk files, hazard analyses, usability reports, GSPR content, IFUs, and STED documentation.

Supported 510(k) renewals, MDR remediation, biocompatibility testing changes, and standards certification by coordinating regulatory documentation with clinical, engineering, and quality teams.

Strengthened labeling compliance across global and local markets by applying FDA, EMA, ICH, ISO, and international labeling requirements throughout the product lifecycle.

Beckman Coulter Staff Regulatory Manager

Mar 2020 - Oct 2022 Chaska, MN / Permanent

Supported IVDD-to-IVDR transition and NPD compliance for immunoassay products by reviewing software transitions, cybersecurity changes, DCPs, clinical documentation, assay changes, supplier changes, device changes, and labeling changes.

Submitted 510(k) content via eSTAR for FALCON NPD and supported high-priority global assay approvals across Asia, the EU, Canada, India, Africa, and South America.

Improved technical-file readiness for the DxI 9000 Immunoassay analyzer by creating traceability matrices and updating CERs, risk files, hazard tables, SRA, PER, PEP, APR, DHF, and change summaries.

Maintained QMS and design-control evidence by reviewing BSI/FDA audits, BOM, DHF, DFMEA, IFU material, drawings, regulatory review forms, global regulatory assessments, and change notifications.

Abbott / Specialist Staffing Quality Engineer

Oct 2020 - Apr 2021 Chaska, Minnesota / Contract

Improved quality-system compliance by supporting FDA 21 CFR Part 820, EU MDR, ISO 13485, CAPA, NCR, risk management, internal/supplier/customer/regulatory audits, and audit-finding closure.

Reduced recurrence risk by conducting root cause investigations, containment activities, product disposition decisions, FMEAs, mitigation planning, quality metrics review, and trend analysis.

Advanced continuous-improvement work by partnering cross-functionally with quality, regulatory, engineering, manufacturing, and supplier teams to improve product quality and process efficiency.

Philips / Black Diamond Regulatory Affairs Manager

Oct 2017 - Dec 2019 Bothell, WA / Contract

Remediated Class III device compliance gaps by implementing processes for 4th Edition, MDR vigilance reporting, MEDDEV changes, end-of-life products, molded tools, and standards updates including CISPR 11, IEC 60601-1, ISO 13485, ISO 10993, and ISO 14971.

Protected market access by submitting PMA supplements, renewing 510(k) devices, updating Class II accessory renewals, and preparing change notifications and memoranda of understanding.

Strengthened risk and technical documentation by updating PMA risk-management and biocompatibility sections, traceability matrices, CERs, hazard tables, control-mitigation tables, V&V content, technical files, and CRB testing evidence.

Improved labeling compliance by reviewing CE marking, CSA certification, domestic/international labeling standards, BOM, NDA, DHF, DHR, safety risk files, product specifications, and engineering specifications.

Johnson & Johnson / DePuy Synthes Senior Regulatory Lead III / Regulatory Affairs III / Complaint Specialist Lead III

Oct 2012 - Jul 2019 West Chester, PA / Permanent

Supported EU MDR classification, labeling, UDI, CE marking, IFU, STG, CER, IVDD, complaint, and post-market surveillance work for Class I, II, III, orthopedic, spinal, CMF, and combination medical devices.

Improved regulatory decision quality by creating gap analyses, risk assessments, essential requirement maps, technical-file remediation documentation, declarations of conformity, and product-change approval assessments.

Maintained complaint and vigilance compliance by assessing adverse-event reportability, reviewing complaints against risk documentation, submitting PMAs/MDRs/MedWatch 3500A reports, and delivering monthly/quarterly trend reports.

Built team capability by training employees on device regulatory requirements, CE marking, complaint processing, MDR decision trees, and software validation expectations under IEC 62304, ISO 9001, ISO 13485, and 21 CFR standards.

Earlier Quality & Regulatory Roles Thermo Fisher, Midmark, Coorstek Medical, Fresenius, Hospira, Southern States Packaging, Tyco/Scott Safety

2007 - 2016 Contract / Corporate Roles

Resolved FDA 483, CAPA, nonconformance, complaint, raw-material, deviation, MDR, PMA, HHE, CER, and supplemental-reporting issues by performing investigations, root-cause analysis, risk assessments, trending, and corrective-action planning.

Supported regulated manufacturing and lab compliance by reviewing DHRs, batch records, line clearance, validation documentation, SOPs, EPA/OSHA/REACH/RoHS requirements, ISO 9000/9001, GMP, GLP, ICH GCP, FDA, and EMA expectations.

Led quality-control and safety-equipment work by managing calibrations, validation reporting, product lifecycle support, UL listings, environmental plans, trial runs, audit preparation, and plant training.

Lead process Improvement projects through Designed Experiments

Statistical Analysis and applying statistical methods to future manufacturing requirements and potential.

EDUCATION

Master of Biomedical Science, Ross University Medical School Biomedical research and clinical rotations

Bachelor of Science, Chemical Engineering, Magna Cum Laude; Minor in Microbiology, St. Andrews Presbyterian College

Chemical Engineering and Pre-Medical Studies, University of North Carolina at Chapel Hill

Contact this candidate