Hello! I’m Maia Kirk, a Regulatory Affairs Executive Leader specializing in Class II/ I II medical devices and IVDs, with deep experience across FDA, EU MDR, IVDR, and Global Frameworks:
Product Development / Design Control
Risk Management
IEC / ISO Compliance
Regulatory Submissions
Gap Assessments
Regulatory Remediation
QMS Modernization
Global Expansion Strategy
I built MKRS to help organizations cut through the noise, reduce risk, and accelerate market access; removing bottlenecks, confusion, and compliance drama.
My philosophy is simple:
✨Regulation should empower innovation, not suffocate it.
Furthermore, when you work with me, you are guaranteed:
✨ Fast execution
✨ A sharp, strategic perspective
✨ Clear, timely communications
✨ Unwavering transparency
✨ And ultimately, regulatory documents so polished they spark joy!