Global QMS and RA manager

331/5000Registration and maintenance of class III and implantable devices in all areas of the world.Management of ISO and authority inspectionsDossier drafting in compliance with both 93/42 / EEC and MDR.Management of labels and IFUManagement of quality and medical Compliant, PMS, RMP and drafting of Clinical Evaluations, PSUR, etc.

Management from the regulatory point of view of the product portfolio (biotechnological drugs, bacterial origin antibiotics, nutraceutical products) of the production site, following the life cycle relatively new submissions and updates. Management of regulatory and quality site documentation. Preparation and revision of Quality/Technical Agreement.Management of new request/updating of CEPPreparation / updating (regulatory writing) of the documentation to be used for regulatory purposes, in collaboration with other company departments involved, in particular preparation and / or updating of:- ASMF and SMF- Documentation required for submission of notifications of changes to the site (essential and not essential) submission to the competent Authority (Expierence with AIFA, Italian Ministry of Health, EMEA, MHRA, B-Farm, ANSM, etc.).- Documentation required to respond to requests from regulators and customers.Inspections activity (GMP, AIFA, FDA, ANVISA and customer inspections)Ensuring the regulatory compliance of the activities of the site; provide adequate regulatory support for all new development projects, defining and preparing the necessary documentation, which must be submissive to the authorities.Working constantly with all operating functions business and interfacing with the Corporate Regulatory Affairs.

Autonomous management of 50 products registered under centralized, MRP, DC and national procedures. Management of medical devices and nutritional supplements. Preparation of the necessary documentation for the start of the registration of new products or for the maintenance of those already on the market (variations, renewals and revisions, recall, DHCP, parallel importation). Autonomous management of contacts with the Ministry of Health / AIFA to ensure a fast and efficient approval. Creation of technical documentation. Definition of regulatory and commercial strategy to be adopted. Updating of various components of the packaging and of all the databases. Exchange of information with all business departments.