Experience

Evolved By Nature

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director of Regulatory Affairs

  • Sep 2022 - Present



Hugel Aesthetics

• United States
• Wellness and Fitness Services
• 1 - 100 Employee

• Director of Regulatory Affairs

  • Jul 2021 - Sep 2022



AbbVie

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Manager Regulatory Affairs

  • May 2018 - Jun 2021



MicroVention-Terumo

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Regulatory Affairs Manager

  • Nov 2017 - May 2018



Allergan

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Regulatory Affairs Manager

  • Mar 2016 - Nov 2017

• Regulatory Affairs Specialist

  • Jun 2014 - Mar 2016

• Senior Regulatory Affairs Associate

  • Jun 2012 - Jun 2014

  Preparation of complex regulatory submission documents for regulatory filings in the US and Japan. Participation in global teams by providing regulatory strategy and guidance to the project teams. Review of reports for scientific merit and regulatory appropriateness. Experience with PMA and IDE submissions. Provide regulatory support for an FDA Advisory Committee Meeting. STED preparation to obtain approval of medical devices in Japan. Technical File maintenance to ensure compliance with EU regulations. Show less

• Regulatory Affairs Coordinator

  • Apr 2012 - Jun 2012

  Creation of a compendium compiling the most current physical, chemical, and biocompatibility testing reports for Allergan’s line of breast products in order to support global product registrations.