Experience

Medical Devices Industry

• Medical Equipment Manufacturing
• 1 - 100 Employee

• Director of Regulatory Affairs

  • Sep 2022 - Present



Biotech

• San Francisco Bay Area

• Director of Quality Assurance and Regulatory Affairs

  • Aug 2016 - Apr 2022



Neozene, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• • Apr 2016 - Aug 2016

  Oversaw the development of the Technical Engagements program for Neozene to develop the quality and regulatory consulting team.

• • Mar 2015 - Apr 2016

  • Design and implement total quality management system for the client• Manage and enhance the company CAPA system, ensuring assignment, investigation, root cause analysis, correction, and closure of open company CAPAs• Train management staff to understand and use the CAPA system for an ISO 13485 QMS• Design and implement customer complaint handling process• Provide support and knowledge required for the client to attain ISO 13485 certification• Assist in the design and implementation of the company-wide training system• Author a new quality manual for the client to assist in implementing the company’s new vision of Quality• Author a quality plan to help facilitate the client’s vision of moving toward a total quality system revamp• Assist in the updating of company-wide complaint systems to better facilitate complaint handling• Submit an expedited 510(k) for the client via third party reviewer• Provide FDA Audit support for the client• Manage foreign government registrations and export requirements for medical devices in Japan, Taiwan, Russia, Lithuania, and Canada• Manage projects to research and implement new market requirements for medical device export• Author STED Canadian registration amendments for pre-existing medical products Show less



ZONARE Medical Systems, Inc.

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Specialist

  • Dec 2014 - Feb 2015

  Foreign government registration, Health Canada Technical Files, JIST Japanese Government Tech File Submission Foreign government registration, Health Canada Technical Files, JIST Japanese Government Tech File Submission



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Regulatory Affairs Specialist

  • Jul 2014 - Dec 2014

  Foreign government registration. Pre-market 510(k) submissions, EU Technical Files Foreign government registration. Pre-market 510(k) submissions, EU Technical Files



Trinity Biotech

• Ireland
• Medical Equipment Manufacturing
• 200 - 300 Employee

• Regulatory Affairs / Quality Assurance Specialist

  • Aug 2011 - Apr 2014

  Foreign governement registration, 510(k) clearances, CAPA, Complaint Handling, Nonconforming Product and Processes, Internal Audit, Document Control, Calibration Control. Foreign governement registration, 510(k) clearances, CAPA, Complaint Handling, Nonconforming Product and Processes, Internal Audit, Document Control, Calibration Control.



CFS West, Holdings

• New Century, Kansas

• Quality Assurance Technician

  • Jul 2009 - Oct 2010