Olivier Deroo, Quality and Regulatory Affairs Consultant

Omschrijving

Specialist for Quality and Regulatory Affairs (QARA) / Medical devices

Manage CE marking submission (MDR) , FDA and HEALTH CANADA clearance

Core competences : Programmable electromedical systems (IEC60601-1), Quality Management

System, Usability, medical software (IEC62304), technical files evaluation, audits

Branche-expertise

Talen

Frans
Tweetalig / moedertaal
Engels
Vloeiend

Voorkeuren voor werkplek

Kan op locatie werken

Lyon (tot 50km)

QARA CONSULTING
Quality and Regulatory Affairs Consultant (freelance)
MEDISCHE SECTOR
juni 2024 - Vandaag (2 jaren)
Missions at
MEDUNIQ, ATOUTBIO, SURICOG (62304 and Cybersecurity)
My Medical Assistant , audiology software (MDR certification)
Marquage CE ISO 13485 MDR 2017/745 IEC 62304
KICKMAKER, Engineering services
device expert
BIOTECHNOLOGIE
oktober 2023 - juni 2024 (8 maanden)
I had to build technical documentation for MDR, IVDR, ISO 13485, 510k, in the framework of engineering innovative medical devices.
Internal auditor
EMITECH, LYON,
Electromedical devices expert
MEDISCHE SECTOR
juni 2020 - oktober 2023 (3 jaren en 4 maanden)
Test laboratories, Medical Business Unit, CB Scheme
• Assessment of conformity of technical files (risk management, Usability, software)
IEC 62304 IEC 60601-1 ISO 13485

Raadpleeg alle ervaringen van Olivier

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Aanmelden om te onthullen

SUPELEC
and Computer Sciences Engineering School
1987
SUPELEC
I.C.A.M
and Computer Sciences Engineering School
1984
I.C.A.M

Bekijk de opleidingen die Olivier heeft gevolgd

Electronics Engineer