South Hurstville, New South Wales, Australia
Specialties: Current Good Manufacturing Practice (cGMP: 21 CFR 820) Project management in multi-functional teams Proficient at CAD with SolidWorks Geometric Dimensioning & Tolerancing (ASME Y14.5M-1994) Leading Corrective and Preventive Actions (CAPA) Matlab, C++, MS Word, Excel and Outlook. Finite Element Analysis (FEA) with Cosmos and ABAQUS/CAE Fluency in English, Nepali and Hindi.
Leading global regulatory affairs and quality assurance for SomnoMed, the public medical device company shipping mandibular advancement devices for Obstructive Sleep Apnea.
Regulatory leader driving global strategy, execution excellence, and agency engagement for a world-first Class III cardiac implantable technology. I defined regulatory pathways for development and market expansion, co-authored the modular PMA, and streamlined design- and change-control approvals across FDA, TGA, and EU frameworks. I elevate cross-functional clarity, accelerate regulatory decision-making, and strengthen commercialization readiness — while coaching team growth and building a high-trust culture. Key Impact: Enabled major regulatory milestones advancing the first leadless LV endocardial pacing system toward global commercialization. Skills & Achievements • Led strategy and submissions for Class III Active Implantable breakthrough technology • Co-authored full PMA modules and high-complexity IDE supplements • Led pre-submission regulatory alignment with global regulatory agencies • Managed EU vigilance and multiple field safety corrective actions • Strengthened execution discipline and regulatory readiness across programs • Mentored regulatory professionals and improved cross-functional collaboration
Certified ISO 13485 Lead Auditor