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Regulatory Affairs Specialist with 6+ years of medical device experience supporting U.S. and international submissions for Class II and III products. Skilled in 510(k), EU MDR, labeling, design changes, and cross-functional compliance execution. Proven record of on-time filings, audit readiness, and faster review cycles across new product launches and lifecycle management.
- Led 18 U.S. and EU medical device submissions, including 510(k) and EU MDR change assessments, achieving 100% on-time filing across three product lines.
- Partnered with R&D, Quality, and Clinical teams to resolve 27 regulatory deficiencies, reducing average review cycle time from 21 days to 12 days.
- Maintained global labeling and technical documentation for Class II devices, supporting four successful product launches and zero critical findings during two FDA inspections.
- Prepared regulatory impact assessments for 35 engineering changes, aligning submissions with 21 CFR 820 and ISO 13485 requirements while preventing launch delays.
- Authored and compiled 12 international registration dossiers for Class II and III products, enabling market access in Canada, EU, and Australia.
- Reviewed design change documentation, risk files, and labeling updates for 60-plus SKUs, ensuring submissions met internal timelines and notified body expectations.
- Supported CAPA, complaint, and post-market surveillance activities by translating regulatory requirements into actions, contributing to a 30% reduction in repeat documentation errors.
- Tracked global submission statuses and agency correspondence in eQMS and PLM systems, improving cross-functional visibility and helping leadership prioritize high-risk remediation items.
RAC credential in U.S. medical device regulation.
Internal auditing credential for medical device quality systems.
Academic focus in medical device development, quality systems, and regulatory documentation.
Regulatory Affairs Specialist with 6+ years of medical device experience supporting U.S. and international submissions for Class II and III products. Skilled in 510(k), EU MDR, labeling, design changes, and cross-functional compliance execution. Proven record of on-time filings, audit readiness, and faster review cycles across new product launches and lifecycle management.
- Led 18 U.S. and EU medical device submissions, including 510(k) and EU MDR change assessments, achieving 100% on-time filing across three product lines.
- Partnered with R&D, Quality, and Clinical teams to resolve 27 regulatory deficiencies, reducing average review cycle time from 21 days to 12 days.
- Maintained global labeling and technical documentation for Class II devices, supporting four successful product launches and zero critical findings during two FDA inspections.
- Prepared regulatory impact assessments for 35 engineering changes, aligning submissions with 21 CFR 820 and ISO 13485 requirements while preventing launch delays.
- Authored and compiled 12 international registration dossiers for Class II and III products, enabling market access in Canada, EU, and Australia.
- Reviewed design change documentation, risk files, and labeling updates for 60-plus SKUs, ensuring submissions met internal timelines and notified body expectations.
- Supported CAPA, complaint, and post-market surveillance activities by translating regulatory requirements into actions, contributing to a 30% reduction in repeat documentation errors.
- Tracked global submission statuses and agency correspondence in eQMS and PLM systems, improving cross-functional visibility and helping leadership prioritize high-risk remediation items.
RAC credential in U.S. medical device regulation.
Internal auditing credential for medical device quality systems.
Academic focus in medical device development, quality systems, and regulatory documentation.
