Charlotte Ayala

About Charlotte Ayala

Quality and Regulatory Compliance professional with over twelve years of experience in…

Experience

1. Project Manager

   RQM+

   Jan 2021 — Present

   Global Pharmaceutical, Medical Device, and Combination Products - Complaint Handling and Regulatory Reporting • Primary point of contact for client, team leads, clinicians, and complaint specialists • Accountable for overall project performance and managing a team of 34 individuals • Responsible for monitoring complaint handling metrics and dashboard management • Present weekly project performance reporting data and metrics to senior management • Coordinate with team leads to mitigate team challenges, drive productivity, provide clear guidance and support, and manage team/project resources • Partnered with cross-functional teams to coordinate product training and the integration of device engineering investigations for reported product complaints • Identified continuous quality and process improvement opportunities, including- Coordination, composition, and implementation of SOP Work Instruction for newly launched complaint handling system- Revision of Work Instruction for the complaint handling processes from initial review through closure- Restructuring team resources to reduce the complaint processing lifecycle and increase throughput, improving the complaint review and closure process - Initiated project for the complete overhaul of the Reportability Matrix for regulatory reporting assessment to drive consistency in regulatory reporting - Initiated project for the development of a best-practices document to drive consistency in the complaint handling process • Successfully supported client as the Audit Coordinator in a 3-week internal audit, with no quality or regulatory findings in relation to complaint handling management

Skills

• Compliance Remediation
• Class Iii Medical Devices
• Ansm
• Customer Service
• Capital Equipment
• Microsoft Office
• Corrective and Preventive Action (Capa)
• Quality Assurance
• Vigilance Reporting
• Mdr Reporting
• Regulatory Compliance
• Standards Compliance
• Technical Writing
• U.s. Food and Drug Administration (Fda)
• Team Building
• Public Speaking
• 21 Cfr 803 Title 21
• Quality System
• Capa
• Medical Devices
• Afssaps
• Mindfulness Meditation
• Bfarm
• 21 Cfr Part 11
• Strategic Planning
• Project Management
• Cross-Functional Team Leadership
• Fda
• Mhra
• Iso 13485
• Gmp
• Class Ii Medical Devices
• Sop Development
• Regulatory Affairs
• Validation
• Regulatory Analysis
• Leadership
• Fda Gmp
• Motivational Speaking