ASHLYN LIGHTFOOT
Dallas,TX
Summary
7 years building an exceptional foundation of knowledge and relationships in the medical industry. Well versed in performing complaint investigations, FDA reporting, and medical device regulatory compliance at a high level. 10 years of experience collaborating effectively with cross-functional colleagues on internal and external teams.
Overview
8
8
years of professional experience
Work History
Complaint Processing Analyst
AbbVie
10.2020 - 07.2025
- Globally trained in record processing, with extensive experience in complaint investigations, FDA reporting, and global medical device regulatory compliance.
- Qualified legal record processor and new hire trainer, developed expertise in coding complaints, managing incoming and outgoing mail, maintaining electronic data filing systems, and ensuring timely and accurate processing of complaint files.
- Generated metric reports to track performance, maintain strict timelines for reportability decisions, and consistently uphold patient safety and privacy practices.
- Deliver clear communication with healthcare professionals and the FDA to assess risks related to implanted medical devices, while adhering to company and regulatory protocols.
- Actively trained employees on record processing, managing multiple records simultaneously, and delivering timely, compliant resolutions that support both patient safety and organizational efficiency.
- Create and review documentation to ensure compliance with GMP standards for regulatory filings and/or reporting for Medical Device Reports and Ministry of Health inquiries.
Outside Medical Laboratory Sales
Chabado Genomics
01.2018 - 05.2020
- Extensive experience generating new accounts and driving growth in the medical marketplace by consistently reaching sales targets within set deadlines.
- Routine customer visits, product demonstrations, and prompt issue resolution, developed and strengthened account relationships while positioning myself as a trusted expert.
- Mastered product knowledge and effectively differentiating solutions from the competition, provided value that builds lasting client trust.
- Work efficiently both independently and as part of a regional team, making sound decisions and leveraging available resources to meet customer needs.
- Sales experience in Upper Respiratory Pathogen, Upper GI, and Urine Toxicology Testing.
Education
Bachelor of Science - Biology
The University of Texas At Arlington
Arlington, TX01.2018
Bachelor of Science - Business Marketing
The University of Texas At Arlington
Arlington, TX01.2016
Skills
- Global medical device compliance
- Enhance efficiency
- Client relations management
- Compliance reporting
- Literature Review and Journal Article Processing
- New hire training coordination
- CAPA and Regulatory CAPA Management
- Medical Device Reporting Regulatory Compliance (CAPA, GMP, GLP, GCP, EU)
Timeline
Complaint Processing Analyst
AbbVie
10.2020 - 07.2025
Outside Medical Laboratory Sales
Chabado Genomics
01.2018 - 05.2020
Bachelor of Science - Biology
The University of Texas At Arlington
Bachelor of Science - Business Marketing
The University of Texas At Arlington
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