Gabriela McLellan
Rancho Santa Margarita
Summary
Dynamic regulatory affairs leader with extensive experience at Bio-Rad, excelling in risk assessment and compliance. Proven track record in driving process improvements and enhancing quality management systems, resulting in accelerated market access. Adept at cross-functional collaboration and data analysis, ensuring regulatory adherence and fostering team development.
Overview
15
15
years of professional experience
Work History
Manager II, Regulatory Affairs
Bio-Rad
05.2024 - Current
- Drive regulatory strategy for new product development, providing input during design transfer, product launch, and global registrations accelerating market access and aligning with strategic growth objectives.
- Managed global registrations and renewals, maintaining submission compliance for uninterrupted market availability.
- Oversee IVDR compliance initiatives, completing labeling conversions, product registrations, and technical file updates ahead of regulatory deadlines.
- Directed global regulatory activities, securing certification continuity and enhancing process improvements to promote cross-functional collaboration.
- Controlled compliance with DEA regulations and ensured IVDR readiness by directing employee development initiatives.
- Oversaw DEA controlled substance compliance, implementing process enhancements to improve tracking accuracy and ensure audit readiness.
- Established and led Sustaining and Design Review Teams, optimizing resource planning, reducing project delays, and enhancing cross-functional collaboration.
- Manage QSD internal audit program, strengthening audit strategies, expanding auditor competencies, and improving overall compliance scores.
- Bio-Rad - Irvine & Ft Worth Site
Manager II, Global Post Market Surveillance
Bio-Rad
02.2023 - 05.2024
- Fulfilled role of Person Responsible for Regulatory Compliance, ensuring effective adherence in Post Market Surveillance.
- Developed Global Post Market Surveillance process ensuring compliance with IVDR requirements.
- Updated global procedures for alignment with IVDR requirements, enhancing regulatory adherence.
- Completed PMS Plans and Reports to meet regulatory requirements.
- Performed organizational development and capacity planning.
Sr. Manager, Quality Systems
Advanced Sterilization Products
Irvine
09.2018 - 02.2023
- Oversaw quality and compliance of the global complaint handling and regulatory reporting organization.
- Ensure compliance with FDA, MDV, and Global Regulatory reporting.
- Ensure compliance with complaint investigation activities, including Failure Analysis Lab.
- Supervised non-conformance management and CAPA implementation, ensuring adherence to quality standards through thorough failure analysis.
- Presented complaint data insights during Quality System Management Review, facilitating informed decision-making.
- Work cross-functionally with New Product Development, Lifecycle Management, R&D, and Supplier Quality.
- Lead Front Room and Back Room audits.
MDR/Vigilance Manager
Medtronic Neurovascular
Irvine
02.2017 - 09.2018
- Managed quality and compliance processes within Global Complaint Handling Organization to uphold regulatory standards.
- Oversaw regulatory reporting decisions for MDR, EU, and Canada.
- Monitored and ensured compliance with Medical Device Reports (MDRs) from regulatory agencies to mitigate risks.
- Prepared and submitted responses to health authority inquiries such as the FDA and competent authorities.
- Supported front room audits to uphold quality standards and ensure adherence to regulatory requirements.
- Maintained department goals to support business.
Sr. MDR/Vigilance Specialist/Lead
Medtronic Neurovascular
Irvine
02.2015 - 02.2017
- Analyzed adverse events and malfunctions based on FDA and International regulations to determine reportability.
- Prepared and submitted regulatory reports to the FDA and competent authorities.
- Developed internal systems and procedures to ensure compliance and enhance post-market surveillance effectiveness.
- Contributed to strategy development for regulatory reporting policies by utilizing event investigation and regulatory decision models.
- Developed and performed training for proper complaint reporting to comply with FDA regulations.
- Analyzed and evaluated workflows and computer processes to enhance work efficiency and improve customer service.
- Provided backroom/front room support for internal/partner audits.
Product Safety Lead
Abbott Medical Optics
Santa Ana
05.2013 - 10.2014
- Initiated and investigated corrective and preventive actions (CAPAs) to address quality issues.
- Developed and conducted training for commercial company employees on complaint reporting procedures to ensure FDA compliance.
- Prepare and submit regulatory reports to the FDA and competent authorities.
- Analyzed monthly trend reports to pinpoint potential product manufacturing issues, facilitating timely interventions.
- Led multiple projects to enhance process improvement initiatives, ensuring alignment with quality standards.
Senior Quality Complaint Specialist
Actavis-Watson Pharmaceuticals
Corona
06.2011 - 05.2013
Education
Master of Legal Studies (MLS) - Pharmaceuticals and Medical Device
Seton Hall Law
06-2025
B.A. - Criminology, Law and Society
University of California, Irvine
01-2012
Skills
- Regulatory compliance
- Risk compliance
- Regulatory strategy
- Regulatory process optimization
- Compliance monitoring
- Quality assurance
- Data analysis
- Data analysis and interpretation
Timeline
Manager II, Regulatory Affairs
Bio-Rad
05.2024 - Current
Manager II, Global Post Market Surveillance
Bio-Rad
02.2023 - 05.2024
Sr. Manager, Quality Systems
Advanced Sterilization Products
09.2018 - 02.2023
MDR/Vigilance Manager
Medtronic Neurovascular
02.2017 - 09.2018
Sr. MDR/Vigilance Specialist/Lead
Medtronic Neurovascular
02.2015 - 02.2017
Product Safety Lead
Abbott Medical Optics
05.2013 - 10.2014
Senior Quality Complaint Specialist
Actavis-Watson Pharmaceuticals
06.2011 - 05.2013
Master of Legal Studies (MLS) - Pharmaceuticals and Medical Device
Seton Hall Law
B.A. - Criminology, Law and Society
University of California, Irvine