Freelancer profile translated to English.

Back to original language

Languages

English
Native or bilingual
French
Native or bilingual

Workplace preferences

Can work on-site

Lyon (up to 50km), Grenoble (up to 50km), Valence (up to 50km), Annecy (up to 50km)

HQR CONSULTING
Founder and Manager
BIOTECH
March 2023 - Today (3 years and 3 months)
Lyon, France
Audit: CQI/IRCA ISO13485 certified
Internal Audit ISO13485:2016 - MDSAP
Training
Regulation 2017/745
Risk Management (14971 - 24971)
Clinical Evaluation (Meddev2.7/1rev4, MDCG, MDR2017/745, Clinical Evaluation Plan and Report) > 50 CER written and/or reviewed and approved - classes I to III
Post-Market Surveillance (PMS, PSUR, PMCF...) and Vigilance
Quality Management Systems (implementation and maintenance)
Operational Quality (NC, CAPA, change control, complaints, batch release...)
Qualification and Validation (sterilization, sterile packaging, transport & storage...)
FDA (510k, 21CFR, Guidances, ASTM, AAMI...)
Clinical Evaluation Audit Quality Management Risk Management Regulatory Affairs
3-D MATRIX
QA Project Manager
BIOTECH
January 2020 - February 2023 (3 years and 1 month)
Caluire-et-Cuire, France
Management of the Quality Management System (ISO 13485:2016 and MDSAP certified for Brazil, Australia, and Canada)
Process Qualification / Validation - including sterilization (aseptic filtration - autoclave - gamma - EtO) and sterile packaging
Management of NC, CAPA, complaints & change control
Release of Class III Medical Device batches
Management of subcontractors and distributors
Training and skills management
Quality Management Qualification Validation Batch Release Supplier Management
EFOR
Technical QARA Manager
BIOTECH
September 2016 - September 2019 (3 years)
Champagne-au-Mont-d'Or, France
• Strategic consulting for the market launch of Medical Devices of all classes (Europe - USA & International)
• Management & Technical Supervision of consultants
• Drafting, verification, and approval of Clinical Evaluation Reports (creation and supervision of the first CER platform - EFOR)
• Preparation and submission of regulatory technical files (Europe - USA & International) & Management of Notified Body audits
• Vigilance Management
• Drafting, verification, and approval of Biological Evaluation Reports
• Conducting internal audits according to ISO 13485:2016
• Creation and updating of Quality Management Systems
• Operational quality management (NC, CAPA, complaints, change control, batch release…)
Consulting Audit Quality Management Clinical Evaluation Regulatory Affairs

Check out Sophie's experience

Be the first to recommend Sophie

Help this freelancer shine by sharing your experience working together.

Agatha Frydrych

Backend Java Software Engineer

4.7

(3)

Baptiste Duhen

Fullstack developer

4.6

(4)

Amed Hamou

Senior Lead Developer

(2)

Audrey Champion

Web developer

4.3

(3)

Signup to reveal

Engineering Degree
INSA Lyon
2015
Diplôme d'ingénieur
Master
Université Claude Bernard Lyon 1
2015
Master

Lead Auditor CQI/IRCA 13485
BSI
2024
Audit

Sophie Amant

Expert Consultant QARA Medical Devices

About Sophie

Experience

Recommendations

These freelancer profiles also match your criteria

Education

Certifications

Categories