Job Overview Recornea Srl is a medical technology company developing minimally invasive therapeutic solutions for treating diseases of the eye. Our core technology focuses on implantable medical devices in nitinol. In particular, we developed an innovative corneal implant for keratoconus, which is under clinical investigation in a first in human clinical trial. As part of our pipeline, we are expanding the application of our core technology to other fields in ophthalmology, such as glaucoma. We are ISO13485-certified company for the design, development, manufacturing and distribution of therapeutic solutions for treating eye diseases in ophthalmology. As a growing company, we are now recruiting a Quality Assurance (QA) and Regulatory Affairs (RA) Manager. The QA/RA Manager serves as a strategic pillar at Recornea, ensuring that our innovative ophthalmic solutions meet the highest global standards for safety and efficacy. This role bridges the gap between clinical innovation and global market availability. Responsibilities QMS Oversight & Maintenance Develops, maintains, and continuously improves the QMS in compliance with ISO 13485:2016, ISO 14971, EU MDR, FDA 21 CFR Part 820 and other regulations ensuring it scales with the company's growth. Develops, implements and customizes templates, SOPs, policies, etc. in accordance with ISO 13485:2016. Ensures compliant updated documentation and records management systems, ensuring documentation is always "audit-ready". Leads cross-functional quality planning in collaboration with R&D;, Clinical to ensure compliance throughout the product lifecycle, from design freeze to market. Develops and manages the company training plan, ensuring all staff are proficient in quality procedures and updated on applicable evolving industry regulations. Establishes and tracks quality metrics and KPIs, reporting QMS performance directly to the CEO and drives initiatives to improve product/process quality and op