Alok Kumar Soni

Accomplished regulatory and quality assurance leader with extensive experience in managing and directing regulatory affairs across leading healthcare companies, including Bio-Rad Laboratories, Fresenius Kabi, and Siemens Healthcare. Demonstrates expertise in enterprise regulatory leadership, quality management systems implementation, and product registration strategy. Proven track record in workflow automation, internal and external supplier audits, and cross-functional leadership. Adept at CAPA and complaint handling as well as regulatory policy advocacy. Committed to driving excellence in quality assurance while advancing career goals towards innovative solutions in the healthcare sector.

• PMP-PMI, 3544941, 2029-06-10
• Six Sigma Black Belt, Ongoing, 2026-07-01
• Certified Lead Auditor ISO 9001, 2015
• Certified on ISO 13485

Accomplished regulatory and quality assurance leader with extensive experience in managing and directing regulatory affairs across leading healthcare companies, including Bio-Rad Laboratories, Fresenius Kabi, and Siemens Healthcare. Demonstrates expertise in enterprise regulatory leadership, quality management systems implementation, and product registration strategy. Proven track record in workflow automation, internal and external supplier audits, and cross-functional leadership. Adept at CAPA and complaint handling as well as regulatory policy advocacy. Committed to driving excellence in quality assurance while advancing career goals towards innovative solutions in the healthcare sector.