Hiram Rada

- Direction of divisions (22 people): Transverse management of Development (8), Quality Assurance (10), and Regulatory Affairs (4) teams. Budget, recruitment, and skill development management.

- Regulatory Strategy & Compliance: Transition from MDD to MDR. Responsible for vigilance (FSN/FSCA), PMS, and technical documentation for global device registration.

- Operational Excellence (QA): Supervision of the Quality Management System (QMS): audits, CAPA, KPIs, non-conformity management, and notified body audits.

- Innovation & Lifecycle: Direction of the development of a new generation medical device (Class IIb) (budget €8M) and management of the lifecycle of existing products.

- Governance: Strategic partner to Top Management and interface with global functions (Marketing/Sales, Purchasing, Production, HR) and management of external partners.

- Transition Management (2020 - 2022): Took over the Belgian team (10 employees) and its activities in parallel with headquarters activities in Germany.

- Management & Leadership: Led a multidisciplinary team of 10 people; managed performance and resources.

- Project Governance: Global management (schedule, budget, risks) and strategic reporting to Senior Management.

- Compliance & Quality: Coordinated technical documentation according to critical regulatory requirements (CE marking).

- Global Interface: Managed cross-functional relationships (Quality, Purchasing, Production, Marketing) and managed external partners/suppliers.