Gandhali Salvi

WORK HISTORY

EDUCATION

ABOUT GANDHALI SALVI

Regulatory Affairs professional with a Master of Science in Regulatory Affairs and about 5 years of global experience leading FDA and EU MDR submissions for Class II and medical devices, including PMA Supplements, 510(k)s, and Technical Documentation. I specialize in developing regulatory strategies, managing sustaining submissions, and ensuring compliance for Class II and medical devices. My experience spans the full product lifecycle—from early regulatory strategy and design change assessments to post-market compliance, vigilance, and audit readiness. I’ve led MDR transition initiatives, authored 510(k) and PMA submissions, supported FDA inspections and Notified Body audits, and collaborated cross-functionally to streamline global market access.Passionate about advancing patient safety and access, I’m driven to help innovative and life-changing medical devices reach patients more quickly through smart, compliant, and least burdensome regulatory pathways.Core Expertise: FDA Submissions (PMA, 510(k)) • EU MDD/MDR Technical Documentation • Global Regulatory Strategy • Change Management; No-File Justifications • Post-Market Surveillance • Risk Management (ISO 14971) • NB Audit support; Inspection Support • Cross-Functional Leadership