Supported a start-up medical device company bringing a novel technology to market, I was responsible for quality and regulatory affairs strategy development and execution, including:- Identification and implementation of an eQMS software tool and creation of quality system processes that were practical and efficient.- Appropriately classify the device in development and determine best regulatory pathway to market (510(k), De Novo, Breakthrough Device Program, etc.)

Regulatory Affairs and Quality Systems- Head of FUJIFILM Sonosite regulatory affairs and quality systems while reporting to the company President- Direct domestic and international regulatory strategies for new and modified class I/II software-driven medical devices- Responsible for execution of quality system that is compliant with domestic and international standards and regulations-Ensure marketing collateral and product labeling follows the regulations of each country in which FUJIFILM Sonosite products are soldCorporate Compliance-Responsible for corporate and healthcare compliance activities, including but not limited to: Foreign Corrupt Practices Act (FCPA), Anti-Money Laundering (AML), U.S. Export Controls, Physician Payments Sunshine Act-Responsible for employee training on compliance regulations and initiatives

Led a team responsible for all FUJIFILM SonoSite domestic and international regulatory product submissions/registrations, along with pre-market regulatory planning and new regulation guidance. Coordinated projects with international offices, distributors and consultants to gain market clearance in rest of world with more efficiency to help maximize revenue opportunity in each market.

Domestic and international regulatory submissions for class II medical devices. FDA 510(k), Japanese STED, Health Canada, EU. Works with other international offices and distributors to gain market clearance in ROW.

Focused on regulatory compliance of SonoSite's quality system. Complaints, CAPA, and internal auditing.