Alessandro Giuliano

Global Regulatory Affairs Manager @Medela

Baar, CH

Consultancy and active support of project teams during the development of new products and the product lifecycle in terms of questions related to risk management, product safety licensing as well as standards, guidance documents, and marketing material/labelling. Focus on active devices, incl. embedded firmware.• Perform country registrations and renewals worldwide (EU & 50+ countries), labelling reviews/releases as well as change control assessments. Set, lead and implement the regulatory strategy.• Responsible for worldwide type approvals of company portfolio of wireless products, incl. mapping and activities lead for radio-equipment requirements.• Support key relationships with NB and European as well as International CA, incl. the FDA as author of a Traditional and a Special 510(k) submission.• Follow the changes to MDR and support of testing activities related to the standards (electrical safety, environmental and packaging, sterilization, biocompatibility, etc.) relevant for products under direct lead.• Monitor regulatory requirements, incl. communication and distribution in a level-appropriate manner through impact assessment tasks. Define and provide training on regulatory submission topics.• Creation and continuous improvement of regulatory related processes. Establishment and maintenance of the regulatory process-related documentation within the product lifecycle.• Independent review of technical documentation according to specific international laws and guidance documents relevant for medical and non-medical devices.• Front Office/Back Office support during internal/external regulatory audits.

Cranfield University

Doctor of Philosophy (PhD), Enhanced piezoelectric energy harvesting powered wireless sensor nodes, using passive interfaces and power management approach

ATHENA Cultura Formazione Comunicazione

Responsible for Prevention and Protection Services (RSPP), Occupational Safety and Health Technology/Technician

Ashorne Hill Management College

CMI Level 5, Project Management

University of Utah

Visiting Research Student, Computational electromagnetics

Sapienza Università di Roma

Master of Science (MSc), Bioengineering and Biomedical Engineering

Università degli Studi di Messina

Bachelor of Science (BSc), Electrical, Electronics and Communications Engineering