Carrie Baines
Bluff City,TN
Summary
Professional with robust experience in regulatory affairs, well-equipped to navigate complex compliance landscapes and drive successful outcomes. Skilled at interpreting regulations, preparing submissions, and managing documentation. Strong focus on team collaboration, adaptability, and achieving results in dynamic environments. Known for effective communication, analytical thinking, and problem-solving abilities.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Assistant to the CFO
Economy Beauty Supply
Bristol, TN
06.2025 - Current
- Coordinated communication between finance department and other teams to streamline operations.
- Analyzed financial data to identify trends, providing insights for executive discussions.
- Assisted in the development of key performance indicators for financial reporting purposes, enabling senior management to effectively monitor company progress against strategic objectives.
- Maintained compliance with regulatory requirements, ensuring timely submission of accurate financial reports to relevant authorities.
- Served as a trusted advisor to the CFO on matters relating to company finances, risk management strategies, and long-term planning considerations.
- Supported CFO in strategic decision-making by providing insightful financial analysis and recommendations.
- Reduced operational costs by identifying areas for improvement and proposing cost-saving measures to senior management.
- Processed travel expenses and reimbursements for executive team and senior management group.
- Worked with senior management to initiate new projects and assist in various processes.
Complaint Analyst
Pfizer
Remote
10.2024 - 06.2025
- Analyzed customer complaints to identify trends and root causes, enhancing product quality assurance for Pfizer's combination products, including Class II and Class III devices.
- Collaborated with cross-functional teams to develop corrective action plans for recurring issues.
- Conducted thorough investigations of reported complaints, ensuring compliance with regulatory standards.
- Contributed to complaint backlog reduction that enabled the team to meet and maintain critical KPI's including less than 5% open over 60 days.
Complaint Specialist
Olympus
08.2021 - 04.2024
- Responsible for global complaints handling from initial intake, reportability assessment, escalation, complaint investigation, and closure.
- Responsible for reportability assessments and downgrades when necessary.
- Collaborated with cross functional departments including Technical Support, Field Service, R&D, Manufacturing, and Quality Assurance, to determine root cause and drive timely complaint closure.
- Applied systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving complaints.
- Maintained compliance to internal complaints procedures and global regulations through GDP and assured complaints were processed in accordance with applicable SOPs.
- Met performance numbers, kept up with the ever-increasing high volume of complaints, and helped with other requests as needed.
- Continuously looked for ways to improve the complaint process and suggested process improvements when applicable.
Regulatory Specialist
Henry Schein dba US Endodontics
03.2019 - 07.2021
- Official correspondent with FDA, Health Canada, and other regulatory agencies as required.
- Provided business and product information to international regulatory staff to enable development of strategies and requirements and communicate that information to business teams.
- Supported maintenance of the quality system while maintaining vigilance and reporting non-compliances and nonconformities as required.
- Supervised Document Control, Internal Auditors, and Complaint Handling.
Quality Lab Supervisor
Henry Schein dba US Endodontics
03.2018 - 03.2019
- Maintained a highly efficient quality lab while mentoring which led to two direct reports becoming ISO 13485 Lead Auditors.
- Supervised training of document Control, GDP, complaints, product return handling, and post market surveillance training given by direct reports.
- Assisted with complaint investigations, closures, customer follow ups, and reportability assessments as needed.
- Created full processes with all related work instructions, forms, and templates to conduct new processes.
Internal Audit Coordinator
Henry Schein dba US Endodontics
03.2017 - 03.2018
- Created and maintained an internal audit schedule that passed several notified body ISO 13485 and MDSAP audits.
- Lead the ISO 13485:2016 and MDSAP transitions by identifying gaps during audits and working with process owners to meet new requirements.
- Supported maintenance of the quality system, maintaining vigilance, and reporting noncompliances and non conformities as required.
Education
Bachelors - Business Administration Management
American National University at Salem VA
01-2020
Skills
- QMS Development
- Gap Assessments / Audit Preparedness
- Complaint Handling
- Complaint Investigation
- Supplier Quality
- Safety Risk Assessment
- Post Market Surveillance Reporting
- FDA
- Health Canada
- EU MDR
- ISO 13485
- ISO 14971
- Bank reconciliation
- Accounts receivable
- Accounts payable
- Payroll processing
- Strong problem solver
- Staff management
- Project management
Certification
- ISO 13485:2016 Lead Auditor BSI March 2017
- Regulatory Affairs Certificate: Medical Devices RAPS July 2024
- Foundation in Regulatory Affairs Certification RAPS February 2026
Timeline
Assistant to the CFO
Economy Beauty Supply
06.2025 - Current
Complaint Analyst
Pfizer
10.2024 - 06.2025
Complaint Specialist
Olympus
08.2021 - 04.2024
Regulatory Specialist
Henry Schein dba US Endodontics
03.2019 - 07.2021
Quality Lab Supervisor
Henry Schein dba US Endodontics
03.2018 - 03.2019
Internal Audit Coordinator
Henry Schein dba US Endodontics
03.2017 - 03.2018
Bachelors - Business Administration Management
American National University at Salem VA
Software
- Microsoft Office
- Trackwise
- Agile
- Power Bi
- SalesForce
- ETQ Reliance
- Argus
- Veeva Vault