Experience

Mozarc Medical
• United States
• Medical Equipment Manufacturing
• 200 - 300 Employee
• Sr Project Coordinator RA

  • Mar 2023 - Present


Medtronic

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Regulatory Affairs Consultant

  • Mar 2022 - Mar 2023

  Main activities: Support for IDE (Investigational Device Exemption) Submission to FDA; Support for Regulatory strategy on new project; Team activities coordination Main activities: Support for IDE (Investigational Device Exemption) Submission to FDA; Support for Regulatory strategy on new project; Team activities coordination



Bios S.r.l.

• Italy
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Regulatory Affairs Associate

  • Jan 2021 - Feb 2022

  Main activities: - Compile, prepare, review and submit regulatory submission to Competent Authorities (Europe, USA, Canada, APAC, EMEA) - Interaction with regulatory Authorities during the development and review process to ensure submission approval - Evaluate regulatory impact of proposed changes in approved medical device - Monitor impact of changing regulations on submission strategies - Mantain of annual licences, registrations and listings - Mantain of Medical Device conformity compliance according with International Standard and Guidelines - Labelling review for compliance before medical device release - Collaboration in the Risk Analysis and Risk Management - Ensure product safety issues and events are reported to Competent Authorities - Post-Market surveillance for Medical Devices - Support during Quality Management System and product certificate audit Show less



SENTINEL CH. S.P.A.

• Regulatory Affairs Specialist

  • Jul 2017 - Dec 2020

  Main activities: - Compile, prepare, review and submit regulatory submission to Competent Authorities (Europe, USA, Canada, Australia, LATAM, APAC, EMEA,) - Interaction with regulatory authorities during the development and review process to ensure submission approval - Registration and update of IVD Medical Device on the Italian Repertory of Medical Device - Review of technical reports, summary documents, labeling documents of IVD Medical Device for appropriate content and adherence to International Standards and Regulatory Guidelines - Collaboration in the Risk Analysis and Risk Management - Mantain of annual licences, registrations and listings - Mantain Medical Device conformity compliance according with International Standard and Guidelines - Evaluation of the regulatory impact for proposed changes in approved medical device - Post-Market surveillance of IVD Medical Devices (Recall, Medical reporting, FSN, FSCA) - Monitor impact of changing regulations on submission strategies - Support during Quality Management System and product certificate audit Show less



L.I.F.E. Corporation S.A.

• Quality Control Manager

  • Jun 2016 - Jun 2017

  Main activities: - Implementation and maintenance of a Quality Management system according to legal compliance (D.Lgs 93/42/CE, ISO13485) and customer expectations. - EC marking and FDA approval of Medical Device - Collaboration with clinicians and physicians - Clinical/research studies startup and development Main activities: - Implementation and maintenance of a Quality Management system according to legal compliance (D.Lgs 93/42/CE, ISO13485) and customer expectations. - EC marking and FDA approval of Medical Device - Collaboration with clinicians and physicians - Clinical/research studies startup and development



Elettronica Biomedicale Srl

• Italy
• Medical Practices

• Clinical Engineer

  • Apr 2013 - Jun 2016

  Main activities: - Management of hospital medical equipment maintenance - Definition of scheduled preventive maintenances according to hospital policies - Service and supplier Agreement - Coordination of technicians staff - Coordination of the Support center for contract management at technical and administrative level Main activities: - Management of hospital medical equipment maintenance - Definition of scheduled preventive maintenances according to hospital policies - Service and supplier Agreement - Coordination of technicians staff - Coordination of the Support center for contract management at technical and administrative level



Italian National Institute of Health

• Co-worker

  • Feb 2010 - Sep 2010

  Collaboration as researcher in the field “Three-dimensional micro-CT investigations for the evaluation of the osteoblast differentiation" at the Dipartimento di Tecnologia e Salute of the National Institute of Health Collaboration as researcher in the field “Three-dimensional micro-CT investigations for the evaluation of the osteoblast differentiation" at the Dipartimento di Tecnologia e Salute of the National Institute of Health