Experience

The Weinberg Group
• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee
• Vice President, Medical Devices & Combination Products

  • Jul 2020 - Present


FDA

• Canada
• Advertising Services
• 1 - 100 Employee

• Senior Reviewer

  • Oct 2016 - Jul 2020

  - Led the review of a wide variety of respiratory devices, including ventilator, lung ablation, diaphragmatic pacing, CPAP, nebulizer, and bronchoscopic accessory devices- Division lead for early feasibility study development and review- Member of the Partnering with Patients Steering Committee

• Policy Analyst (detail)

  • Oct 2018 - Apr 2019

  Provided clinical trial policy support to internal and external stakeholders

• Branch Chief, Division of Patient Safety Partnerships

  • Aug 2014 - Oct 2016

  Oversaw the review of MedSun hospital submitted adverse event and voluntary medical device reports. Engaged with the clinical community to increase reporting and gain real-world perspectives to aid in regulatory decision making.

• Lead Reviewer

  • Mar 2007 - Aug 2014

  Led the review of cardiovascular device premarket submissions. Specific areas of expertise include ventricular assist devices, cardiopulmonary bypass circuit components, heart valves, biocompatibility of medical devices and interactions with registries.


Baxter Healthcare
• Australia
• 1 - 100 Employee
• Research Associate

  • Oct 2006 - Mar 2007