Beschreibung

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.

Branchenexpertise

Sprachen

Italienisch
Muttersprachlich oder zweisprachig
Englisch
Verhandlungssicher

Arbeitsortpräferenzen

Vor Ort möglich

Brescia (bis zu 50 km)

Mozarc Medical LLC
RA Program Manager
August 2025 - April 2026 (8 Monate)
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
November 2022 - Juli 2025 (2 Jahre und 8 Monate)
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
November 2021 - Oktober 2022 (11 Monate)
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