Medical Devices and Food Regulatory Affairs

Regulatory and QA services for Medical Devices | |Food supplements and food for special medical purposes: R&D, Regulatory and Registration ServicesActivities:- Due diligence: evaluation of the technical documentation compliance to normative requirements- Realization/support/updating/maintenance of technical files and CE certification applications- Drawing up/Evaluation/Updating and Maintenance of the Quality Management Systems, Quality Manual and SOPs- Audits and preaudits, support during audits performed by Certification Bodies, Notified Bodies or Competent Authorities- Power of attorney/Representation at Notified Bodies, Certification Bodies and Competent Authorities- EU Authorized Representative- Support during regulatory placement of products- Clinical Validation support- Pre-certification strategy and technical-scientific support- Support in CAPA managing and resolution of Product/System Non Conformities- Registration in the national database for medical devices- Compliance to international/local legislations evaluation- Assistance for import-export administrative and regulatory procedures- Free sale certificates and legalizations- Marketing and communication support, business partnership and scientific development

In this position, I coordinate and implement the functions involved in the application and maintenance of the Quality Management System of the Certification Unit (Notified Body 0373) and the related documentation. Moreover, I coordinate the resources belonging to the Quality Management Office.