Marian Vargas

About Marian Vargas

Experienced Quality Assurance & Regulatory Compliance Professional in for both domestic 21 CFR 800s and international markets (ISO 13485), with a expertise in Post-Market Surveillance, Complaint Handling, Medical Device Reporting (FDA), Medical Device Problem Reporting (HC), complaint and adverse event trending, and quality process improvement. Skills: CAPA, cGMPs, Complaint trending and analysis, Complaint Investigation, Consumer Products, Crisis Management (Brand Reputation/Social Media), EPA, FDA, FIFRA Section 6(a)(2), Health Canada, Health Canada Consumer Incident Report, Medical Device Report, labeling, IFU, MDR, Medical Device Problem Report, MDPR, Post Marketing Surveillance, Medical Devices, Reportability Determination, UDI, 21 CFR 803, 21 CFR 820; 40 CFR Part 159, ISO13485, CMDR SOR-98-282, ETQ, Minitab, Spanish (Fluent)Open to new consulting or permanent opportunities, Willing to relocate: Anywhere

Experience

1. Regulatory Affair Product Manager

   Kimberly-Clark

   Jul 2023 — Present

Education

• Georgia Institute of Technology

  MS., Organic Chemistry

  1995 — 1998

• University of Central Florida

  B.S., Chemistry

  1991 — 1995

• Georgia Institute of Technology

  PhD, Polymer Chemistry

  1998 — 2004

Skills

• R&D
• Dsc & Tga Thermal Analysis
• U.s. Food and Drug Administration (Fda)
• Design of Experiments
• Strong Verbal and Interpersonal Skills
• Chemistry
• Standard Operating Procedure (Sop)
• High-Performance Liquid Chromatography (Hplc)
• Gmp
• Uv/Vis
• Uv/Vis Spectroscopy
• Ir Spectroscopy
• Sop
• Fda
• Technology Transfer
• Research and Development (R&D)
• Knowledge of Glp’s Processes
• Hplc
• Characterization
• Analytical Chemistry
• Validation
• Interpersonal Communication
• Glp
• Interpersonal Communication Abilities
• Project Management
• Formulation
• Fluent in Both English, Spanish
• Nmr, Uv-Vis and Ir Spectroscopy
• Medical Devices
• Chromatography