Anne Zavertnik

About Anne Zavertnik

Fueled by a passion for improving access to safe medical technologies for patients worldwide, I have directed initiatives to ensure compliance with not only international regulations but also global quality standards. Accomplished Regulatory affairs, quality assurance and compliance executive with over twenty years\' experience in medical device and in vitro diagnostics (IVD) development. I have a progressive history of accelerating time to market while driving registrations and clearances for groundbreaking IVD products released in over 144 countries worldwide. Recent successful US work with FDA on pre-submission applications and de novo submission requests. Quality leadership successes include obtaining release from a US Warning Letter, an initial ISO 13485 certification for a start-up, and managing facilities in six countries. Proven leader with ability to guide and motivate the efforts of scientists, managers, technicians and staff to complete goals within limited time constraints. Resourceful manager who is skilled in oral and written communication with the capacity to balance multiple assignments. Demonstrated ability to plan and execute broad, multidisciplinary projects with keen attention to detail.

Experience

1. Vice President, Regulatory Affairs and Clinical

   Alpco

   May 2025 — Present

Education

• University of South Carolina

  BS, Biology

Skills

• U.s. Food and Drug Administration (Fda)
• Manufacturing
• Iso 13485
• Glp
• Verification and Validation (V&V)
• Cross-Functional Team Leadership
• Design Control
• Good Laboratory Practice (Glp)
• Medical Devices
• Capa
• Ivd
• Iso
• Pharmaceutical Industry
• Sop
• Fda
• Validation
• Regulatory Affairs
• R&D
• Quality System
• V&V
• Patents
• Software Documentation
• Research and Development (R&D)
• Gmp
• Iso Standards
• Product Development
• Technology Transfer
• Quality Assurance
• Pma
• Standard Operating Procedure (Sop)
• Corrective and Preventive Action (Capa)