Ing. Angelo Di Perna

Gap assessment and remediation planning for technical documentation of CE marked medical devices vs EU MDR requirements.

Responsible for CE marking of medication delivery and nutrition devices produced by 5 internal manufacturing sites and by a complex network of contract manufacturers. EU Regulatory SME for sterilization and custom procedural systems.

Prepare, maintain and keep updated technical documentation for assigned products CE marking. Support change control activities. Prepare RA assessments and RA strategies. Partecipate cross functional teams to support new and modified product development. Support daily regulatory activities for EC and ECEMEA region.

QA and validation Support to improve compliance and reliability of internal and external processes in the field of Sterility Assurance. Project manager to reduce unnecessary tests and focus on more significant aspects using holistic approach and engineering tools. Team Leader in cross-functional teams for Product/process definition, adoption and validation, W-C assessments; RCA and FMEA.

Technical / Plant Manager Medical Device Manufacturing and Contract Sterilization. • Quality Management (ISO 13485). • Sterilization Management (design, validation and control of contract EtO sterilization). • Key account management. • Business development.

Product manager cardiovascular products: • Cardiac rhythm management products • Interventional coronary products • Interventional peripheral products • Vascular sutures

Regional product specialist Vitatron CRM implantable devices.

Regional sales representative for CRM implantable devices.

•Public works and contracts management •Structural design •ISO based Quality System manager •Occupational safety and health

Support implementing and applying a quality system.