Description

Hello, I spent 15+ years in the industry and almost three years as product reviewer at TUV SUD Denmark in the medical device field, with the purpose to prepare or review TD in order to get or release the CE marking for medical devices (class II/III) under MDD and now MDR 2017/745 Regulation. I have also international submission experiences (US, Japan, China, Australia, Canada, India, S. Korea). If you search for a strong background in the documental review or gap analysis and in the assembly of TD to get certificates or license authorizations please, contact me.

Domaines d’expertise

Langues

Italien
Bilingue ou natif
Anglais
Capacité professionnelle complète

Préférences en matière de lieu de travail

Accepte de travailler sur site

Brescia (jusqu’à 50 km)

Mozarc Medical LLC
RA Program Manager
août 2025 - avril 2026 (8 mois)
Mirandola, MO, Italy
RA Program Manager at Mozarc Medical LLC (manufacturer of dialyzer
for chronic/acute therapies and renal access/maintenance products for haemo/peritoneal dialysis), based in
Mirandola, Italy.
Regulatory stretegy Documents review Gap analysis Mentoring and coaching Regulatory changes
EU Notified Body (TUV SUD Denmark ApS)
authorized product reviewer
novembre 2022 - juillet 2025 (2 ans et 8 mois)
Hired by an EU Notified Body (TUV SUD Denmark ApS) as
authorized product reviewer for CE marking of cardio-vascular medical devices (class III/IIb/IIa) under
MDR 2017/745.
30+ trainings with passed final exam in the following areas:
-- MDR 2017/745;
-- Technical Documentation for product certification under MDR;
-- Significant products changes;
-- EN ISO 13485;
-- Biological evaluation per EN ISO 10993 parts;
-- Risk management per EN ISO 14971;
-- Packaging per EN ISO 11607-1/2;
-- Clinical evaluation;
-- Post Market Surveillance;
-- Products associated with the MDR codes: MDN 1101, 1201, 1203, 1208
Product reviewer
Haemopharm Biofluids S.r.l. (owned by Medtronic Plc)
Person Responsible for Regulatory Compliance
novembre 2021 - octobre 2022 (11 mois)
Person Responsible for Regulatory Compliance at
Haemopharm Biofluids S.r.l. (owned by Medtronic Plc), manufacturer of haemodialysis and
haemofiltration bag solutions, based in Tovo S. Agata, Italy.
Responsible for product certification (CE marking) and routine regulatory activities, including Regulatory
assessment/approval for design/process/labelling changes.
Regulatory stretegy Regulatory changes Product reviewer Regulatory strategy Gap analysis