Experience

Blackrock Neurotech
• United States
• Medical Equipment Manufacturing
• 100 - 200 Employee
• Director of Regulatory Affairs

  • Sep 2021 - Present


Medtronic

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

• Senior Manager Regulatory Affairs

  • Jul 2021 - Sep 2021

• Regulatory Affairs Manager

  • Jul 2019 - Jul 2021

• Principal Regulatory Affairs Specialist

  • Nov 2008 - Jul 2019

  - Lead a Regulatory team in multiple FDA and global submission for device software and capital systems- Lead a cross-functional team to prepare global submissions- Develop and implement global regulatory strategies for new products or significant modifications to products - Prepare and gain approval of EU design dossier amendments - Prepare and gain approval of CFDA submission and Health Canada submissions- Interact/negotiate with FDA, CFDA and Notified Body Reviewers - Prepare and maintain EU Technical Files- Collaborate with Clinical personnel to develop Clinical Evaluation Reports - Develop and maintain regulatory SOPs- Support CAPA activities including ownership of individual CAPAs, correction and removal assessments, and health hazard evaluations- Manage global field corrective actions- Provide regulatory support for quality system changes- Front room/backroom support in FDA and Notified Body audits- Participate in corporate change initiative teams- Review advertising and promotional materials for compliance with labeling claims



Amgen

• United States
• Biotechnology Research
• 700 & Above Employee

• Business Analyst

  • Aug 2007 - Nov 2008

  - Support corporate wide SAP implementation - Design and implement training for SAP implementation including process impact - Manage, prioritize and assign incoming issues - Analyze metrics to identify process improvements - Prepare metric data and synopsis for director level staff - Provide support in “war room” at during SAP implementation - Resolve Global ERP issues for internal and external clients - Collaborate with technical staff to resolve issues in a timely manner - Support corporate wide SAP implementation - Design and implement training for SAP implementation including process impact - Manage, prioritize and assign incoming issues - Analyze metrics to identify process improvements - Prepare metric data and synopsis for director level staff - Provide support in “war room” at during SAP implementation - Resolve Global ERP issues for internal and external clients - Collaborate with technical staff to resolve issues in a timely manner