I led the Global Regulatory, Technical Communications, and Clinical Affairs teams for Stryker Medical Redmond (SMR), which produces Automatic External Defibrillators and professional Monitor/Defibrillators. My total organization was 50+ people and supported Class I, II, and III medical devices commercialized in 80+ countries. A large component of my role was partnering with the quality team to lead the EU MDR program, which included the up-classification of AEDs to Class III and revising all product labeling and technical files.

I relocated to Tokyo as an expat with my family to Direct the Japan Electrophysiology (EP) Team of Sales, Marketing, Capital Sales, and Sales Training to achieve our commercial objectives. Building off my previous success in launching Rhythmia in the US, we used the launch of Rhythmia in Japan to revive the Boston Scientific EP business in Japan and grow by over 50%.

I leveraged my project management skillset in the commercial launch of a new acquisition, Rhythmia.

I led a team of technical writers, graphic designers, and localization project managers to create and translate all regulated literature and labeling. With a focus on team engagement, I managed 24 direct reports and built a strong reputation for consistent process and predictable execution. By increasing our focus on project management, I drove team to implement process improvements with savings of over $1M on a $4M budget.

I identified and led cross-functional Value Improvement Projects to reduce cost and/or improve efficiency, focused in our Clinical Affairs team. By leveraging scrum methodologies, I created the clinical “Diamond Site” program to improve clinical trial enrollment and execution and “QuickSite” to reduce clinical start-up times by 50%.

I led multiple new product hardware and software development projects across various locations from project concept through commercialization. Regularly presented to executive management board for phase gate reviews, project updates, and funding approval.

I managed the CAPA process and executed product holds while developing, testing, training, and deploying quality system updates and software tools.