Tara Shelton

About Tara Shelton

Senior Post‑Market Safety Specialist with proven expertise in global vigilance reporting, post‑market surveillance strategy, and regulatory compliance across FDA, EU MDR, and Health Canada frameworks. I specialize in interpreting complex safety data, contributing to PSURs, PMS plans, safety assessments, and driving early detection of product‑related trends and signals. Known for delivering high‑quality technical and clinical analyses, supporting cross‑functional teams in complaint investigations, HHEs, CAPAs, field actions, and strengthening PMS processes through data‑driven insights and continuous improvement. I thrive in collaborative environments, contributing clear medical, regulatory, and technical guidance to ensure product safety and ongoing compliance. I am deeply passionate about consumer product safety and dedicated to process improvement. As a detail-oriented self-starter, I excel in high-pressure environments while managing multiple priorities effectively.Strong experience in Post Market Surveillance and Vigilance writing with over 10 years of experience in Product Quality Vigilance (PQV) and Post Market Surveillance (PMS) with a robust skill set in medical device complaint handling, vigilance writing, and Medical Device Reporting (MDR) for Class I, II, and devices. Well-versed in regulatory requirements and have a proven track record of timely submissions to the FDA and other global health authorities, achieving 100% on-time reporting metrics. My meticulous approach of auditing complaint capture, complaint handling, and compliance ensures the highest standards in vigilance writing and submission.Additionally, as a Subject Matter Expert (SME) in Diabetes Self-Management Training, and Insulin Pump Therapy, I bring exceptional critical thinking and motivational interviewing (MI) skills, to enhance patient outcomes.Upon request, I can provide my resume which will highlight a broad area of experience in the medical industry.Areas of expertise:Patient SafetyProduct Quality Vigilance (PQV) & MDR ReportingQuality Assessments and Assurance Policy & Procedure development, revision & approval routingQuality & Process ImprovementsComplaint Handling & EMR AuditingExcellent Critical Thinking & Data Analyzing SkillsCAPA, Non-Conformance & FMEA SupportInsulin Pump TherapyDiabetes Self-Management TrainingInterested in discussing new remote opportunities, please contact me at t•••••••@sheltonelectrical.com

Experience

1. Senior Post Market Safety Specialist

   Insulet Corporation

   Jan 2026 — Present

Education

• Morehead State University

  AP4 program

• Murray State University

  Bachelor of Science (BS), Dietetics and Food Service Administration