Avi Rozen

* Owned end-to-end global operations across Israel, US (including full US-market operations), and international hubs (London, New York), aligning local workflows with central standards to ensure consistent service delivery across markets. * Directed outsourced medical device production in the Far East with accountability for Quality, Cost and Delivery; managed supplier escalations and CAPA processes to resolve major non-conformities and maintain continuity of clinical supply. * Managed and developed cross-functional Operations, Logistics and Procurement teams across multiple sites, establishing training, onboarding and role accountabilities for distributed staff. * Led complex strategic operational projects end-to-end, including system rollouts (ERP, inventory and reporting) and process transitions to support scale and regulatory compliance. * Designed and implemented Quality Management Systems (QMS) aligned to FDA QSR and international regulatory requirements; led ISO 13485 certification program from planning through final accreditation

* Managed development and production processes across Israel and China, coordinating cross-border teams and vendors to deliver regulated clinical hardware and support clinical service readiness. * Conducted needs analysis and led project management for operational improvements, including process documentation, supplier coordination and production planning to reduce delivery risk.

* Directly managed production and supply chain operations, including contract implementation with subcontractors and oversight of warehouse and inventory procedures. * Produced regular operational reports and statistical analyses on production, inventory and sales to inform capacity planning and procurement decisions.