Christina Boydston

As a seasoned Regulatory Affairs Executive, I bring a wealth of experience across diverse medical device categories. My passion lies in driving cultural change, managing turnaround situations, and transforming regulatory functions from reactive to proactive postures. I excel in process improvement, tackling complex problems, and fostering cross-functional collaboration.

Throughout my career, I've developed a reputation for maintaining a calm demeanor in high-pressure environments. This has been crucial in my role as a subject matter expert in submissions, compliance management, and stakeholder engagement. I've successfully led teams of 25+ professionals, honing my people management skills and earning recognition as an exceptional communicator who can articulate and drive vision.

My track record includes implementing robust auditing processes and supporting new product development, resulting in zero external audit findings from notified bodies, FDA, and various regulatory agencies during my tenure at Zimmer Biomet. One of my proudest achievements was securing 510(k) clearance for a complex infusion pump system at BD - a feat that had eluded the company for five years prior.

I thrive on challenges and am committed to supporting growth in organizations. My goal is to continue leveraging my expertise to drive regulatory excellence and contribute to the advancement of medical device innovation.

Accomplished and passionate Regulatory Affairs Executive with experience across diverse medical device categories. Drives cultural change, manages turnaround situations, and transforms regulatory functions from reactive to proactive posture. Excels in process improvement, complex problem-solving, and cross-functional collaboration.

Leverages calm demeanor in high-stakes environments and serves as subject matter expert across submissions, compliance management, and stakeholder engagement. Manages teams up to 25+, demonstrating skilled people management and is recognized as exceptional communicator who drives vision, while supporting growth and multibillion-dollar organizations.

• Implemented and supported auditing process and new product development, generating zero external audit findings including from notified bodies, FDA, and regulatory agencies throughout tenure at Zimmer Biomet. 
• Received 510(k) clearance on infusion pump system with single central programming and power unit, 3 pump modules, monitoring devices, and 6 supporting softwares, previously not gaining clearance for 5 prior years. 

Bachelor of Science, Biology & Spanish • Brigham Young University

Advanced Certificate in Regulatory Affairs • University of California in San Diego (UCSD)