Paolo Mellino

• Lead team and process for global regulatory distribution controls • Functional lead for site responsibility as EU Authorised Representative under EU IVDD and IVD-R • Process lead for Economic Operator responsibilities under EU IVD-R and MDR • Division lead for regulatory advocacy on EU IVDR program

Responsible Quality function for the Abbott Diagnostics Distribution Centre. Management of the Incoming Quality Control department, Revision Control group to ensure translated inserts match English revisions at by-pack operations, and E-Labelling operations. Control of quality status of distributed finished products. Coordination of supply, launch, and distribution of TPM/OEM finished products.

Responsible Quality function for the Abbott Diagnostics Distribution Centre. Management of the Incoming Quality Control department, Revision Control group to ensure translated inserts match English revisions at by-pack operations, and E-Labelling operations. Control of quality status of distributed finished products. Coordination of supply, launch, and distribution of TPM/OEM finished products.

Maintainance, update and distribution of material safety data sheets for ADD and for AMD products. Maintainance of material safety data sheets (MSDS) database. Implemented ADD web solution for the electronic retrieval of MSDSs. Support of European ADD sites in regards to Product Safety relevant questions. Provision of customs classification according to the European regulations. Classification of dangerous goods according to IATA and DGR regulations. Data Protection Officer for Wiesbaden site.