Aimee Hamilton

About Aimee Hamilton

Experienced Director Regulatory Compliance with a demonstrated history of working in the…

Experience

1. Director Regulatory Compliance & Quality Assurance

   Conduent

   Jan 2017 — Present · Boca Raton, FL, US

   Responsibilities include the design, implementation and administration of the organizations compliance program. Including elements of Corrective and Preventive Actions, Complaint and Adverse Reporting, Nonconformance Controls, Supplier Management, Internal Auditing, Change Management- Lead outside audits for customers, suppliers, regulatory agencies- Provide regulatory support to internal and client stakeholders. Researches sources of regulatory information (ie. Regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc.)- Monitors and interprets existing and updates regulatory and corporate requirements. Benchmark best practices against applicable regulations and update SOPs accordingly

Education

• Drake University

  Bachelor of Science (BS), Biology, General

  1993 — 1997

Skills

• Quality Auditing
• Hipaa
• Standard Operating Procedure (Sop)
• Supplier Quality
• Iso 14971
• Design Control
• Lean Manufacturing
• U.s. Food and Drug Administration (Fda)
• Corrective and Preventive Action (Capa)
• Glp
• Quality System
• V&V
• Sop
• Fda
• Validation
• Tcpa
• 21 Cfr Part 11
• Fmea
• Quality Control
• Medical Devices
• Process Improvement
• Capa
• Continuous Improvement
• Iso 13485