Profile

Regulatory affairs and compliance leader with extensive experience in the global MedTech sector. Proven expertise in managing global complaints, adverse event reporting, large-scale recalls, and regulatory remediation (FDA 483, Warning Letters, Consent Decrees). Skilled in global regulatory strategy, 510(k) submissions, international registrations, EU Medical Device Regulation (EU MDR), technical file updates, labeling, Scientific/Technical writing and post-market surveillance. Strong track record of leading cross-functional teams and delivering regulatory training. Regulatory Affairs Certification (RAC US); leadership roles at Bayer Healthcare and RQM+.