Christina Boydston

Lead the development of global regulatory strategies for new products at Dentsply Sirona, resulting in successful product launches. • Manage software, dental and regenerative tissue submissions in the US including 510(k)s, QSUBs, and 513(g)s, ensuring compliance with regulations. • Provide guidance on US and EU regulations to support product commercialization for cross-functional teams.

Progressively grew with organization within Medical Affairs function and currently play crucial role in shaping regulatory strategies and ensuring compliance for infusion devices, supporting software, and monitoring devices. Act as integral member of infusion leadership team, contributing to development of comprehensive regulatory roadmaps and leading team dedicated to new product development activities within $1B business unit. Directly manage 4-person team. ➤ Oversaw and coordinated complex workstreams, particularly in support of intricate 510(k) submissions including for stalled submission of infusion pump system; navigated leadership changes, cultural shifts, challenges associated with COVID, and coordination of infusion set submissions. ➤ Resolved 3 major notified body findings on infusion pump device within months of being hired. ➤ Partnered with cross-functional team to prepare complicated infusion device system for MDR submission and approval. ➤ Successfully designed and implemented comprehensive standards management process, resulting in improved regulatory compliance while enhancing product quality across organization. ➤ Delivered strategic leadership and navigated cultural changes relating to product development and commercialization of infusion pumps, software, medication management solutions, and monitoring devices. ➤ Provided essential regulatory support during both internal and external audits, demonstrating comprehensive understanding of regulatory requirements and industry standards in medical device sector.

Directed regulatory affairs surrounding transcatheter and mitral repair and replacement devices, guiding products through clinical trials toward PMA submission. Collaborated closely with strategy team to orchestrate comprehensive preparation for PMA, MDD, and MDR submissions while effectively operating in multiple regulatory frameworks. Oversaw staff of 6. ➤ Directly engaged with FDA and notified bodies, managing submissions and device modifications. ➤ Spearheaded transition to MDR compliance for transcatheter and mitral repair and replacement devices, showcasing ability to navigate complex regulatory changes and ensure organizational readiness for evolving standards. ➤ Drove cross-functional collaboration, instrumental in planning and executing animal studies for clinical trial readiness. ➤ Effectively managed and submitted Annual IDE and diverse regulatory reports for transcatheter and mitral repair and replacement devices, ensuring compliance with FDA requirements and standards. ➤ Initiated clinical trials for transcatheter and mitral repair and replacement devices, focusing on accelerating speed to market approval for organization. ➤ Designed and developed comprehensive training materials for transcatheter and mitral repair and replacement device.

Rehired by company to provide leadership to team of 25+ employees, managing complex regulatory and compliance operations. Orchestrated regulatory submissions, complaints, and compliance groups, aimed at accelerating clinical, product development, and commercialization projects. ➤ Successfully provided regulatory and compliance support during transition of all manufacturing and quality operations from California to Florida, navigating registration challenges and overseeing complex manufacturing, design, and registration transfer. ➤ Directed high-performing team of complaint analysts, processing over 500 complaints monthly and consistently delivering timely quarterly FDA reports. ➤ Managed product registrations across diverse portfolios in more than 80 countries globally in key markets including China, Brazil, Japan, Canada, Latin America, US, and EU, demonstrating firm grasp on international regulatory landscapes. ➤ Engineered and implemented robust Quality System Metrics, withstanding rigorous scrutiny from multiple external auditors including notified bodies and FDA, and achieving zero non-conformities across all audits. ➤ Guided staff in successfully obtaining FDA clearance for 7 510(k) submissions including landmark submission that incorporated MRI data and ratings for entire dental implant portfolio significantly enhancing product marketability.

Successfully conducted internal audits, leveraging best practices to enhance regulatory adherence; compiled comprehensive data for FDA 483 responses.

Guided efforts across quality system management, recall processes, and audit support; developed global regulatory strategies, managed CAPAs, and enhanced validation documentation. Served as regulatory subject matter expert on product changes, process changes, new products, and process validation. ➤ Created process to challenge and document Verification and Validation Activities and transition from “Trust Me” style to clear reports to withstand 510(k) registration and audit reviews from global agencies.