Romina Giorgiotti

-Responsible for annual planning and estimation of project budgets and technical resources. -Executed design verification and validation activities in accordance with Medical Device Regulation (EU) 2017/745 (MDR). -Authored and maintained Risk Management Files (ISO 14971) and Requirements Management Files. -Prepared technical documentation, including test protocols, validation plans, and verification reports for regulatory submissions.

-Led planning, coordination, and tracking of R&D projects for Class IIa medical devices (hydrogels and needles). -Facilitated project reviews and progress reporting through regular meetings and dashboards. -Managed supplier evaluation, procurement processes, and acquisition of technical tooling. -Ensured alignment with development timelines, budget constraints, and quality requirements.

-Conducted industrial process performance analysis and implemented improvements in manufacturing workflows. -Led equipment reengineering and process validation initiatives in compliance with ISO 13485. -Developed manufacturing documentation: work instructions, validation protocols, and flow diagrams. -Maintained master data in SAP: materials, BOMs, routings, and other product parameters.