* New position August 2024 - Regulatory & QA Specialist @ Fertil.is *Focus - to obtain certification, registration & entry to market for our product.Responsible for QMS, and all related RA/QA functions. Previous experience:Numedico Technologies:Super User for ISO 13485 implementationRegulatory Specialist in medical devices & health and wellness products, requiring local and overseas registrations.Responsible for global registrations & regulatory requirements.Extensive TGA experience and knowledge.Experience with overseas markets & regulatory requirements.Researching & document validation. Liaising with both internal & external stakeholders.High level administration tasks.* Essential Principles for Medical Device compliance* Data Integrity * Regulatory IntelligencePrevious employment experience:Over 6 years experience in the flavour & fragrance industry - laboratory & regulatory. Regulatory role since 2019.SAP super user for SAP implementation project.EHS super user for APMEA - Safety Data Sheets, IFRA, EU Allergens & compliance engine upgrades to the system as per regulation. Responsible for testing updates in the system & signing off on upgrades. Provide support to the wider team as Super User for the APMEA region.TGA knowledge & experience.Audit experience for QMS, Halal & Kosher.On the Management Committee for FFAANZ (Flavour & Fragrance Association of Australia & New Zealand).Excellent administration skills & attention to detail. Customer focused.Extensive knowledge of fragrance and flavour RA requirements.