Santiago, Krystal

Santiago, Krystal

VP Quality Assurance and Regulatory Affairs at Planet Innovation

Krystal Santiago is Planet Innovation’s VP Quality Assurance and Regulatory Affairs. In this role she leads the global QA team to oversee and manage the Quality System to ensure continual compliance with regulatory requirements.  She also leads the regulatory consulting team to provide PI clients with regulatory guidance.

Krystal brings to the table a rich blend of leadership expertise in Regulatory and Quality management, demonstrating a track record of success within startup and medium to large corporate environments. Her broad-based skill set encompasses regulatory strategy, quality engineering, quality systems management, and statistical analysis. Possessing a unique ability to negotiate and communicate with regulatory agencies on innovative device programs, Krystal effectively challenges regulatory norms to secure necessary approvals. Her prolific contributions extend to authoring numerous IDE, 510(k), and EU product submissions, further exemplifying her in-depth understanding of the regulatory landscape.

Krystal holds a Bachelor's degree in Industrial Engineering from Cal Poly, San Luis Obispo, and a Master's in Applied Statistics from California State University, Long Beach. She has achieved numerous industry-relevant certifications.

Future-Proofing Your Manufacturing Strategy for Regulated Medtech Devices
Thursday, February 8 2:30 PM - 3:15 PM Pacific Time (US & Canada); Tijuana