Olivier Deroo, Quality and Regulatory Affairs Consultant

Description

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

Industry field of expertise

Languages

French
Native or bilingual
English
Fluent

Workplace preferences

Can work on-site

Lyon (up to 50km)

QARA CONSULTING
Quality and Regulatory Affairs Consultant (freelance)
MEDICAL
June 2024 - Today (2 years)
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
BIOTECH
October 2023 - June 2024 (8 months)
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
MEDICAL
June 2020 - October 2023 (3 years and 4 months)
Test laboratories, Medical Business Unit, CB Scheme
• Assessment of conformity of technical files (risk management, Usability, software)
IEC 62304 IEC 60601-1 ISO 13485

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Signup to reveal

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

Check out Olivier's education

Electronics Engineer