Mes compétences :
Solidworks
Microsoft Word
Microsoft PowerPoint
Microsoft Office
Microsoft Excel
Medical Devices
Regulatory Affairs
Entreprises
SYMATESE
- Assistant ingénieur en affaires réglementaires et en R&D
CHAPONOST2015 - 2015Regulatory affair tasks carried out:
- Research inputs data through legislations and guidelines from different non-European countries (Brazil, Mexico, Colombia, South Korea, Australia,…) to register class III medical devices
- Update files and documents for technical file
- Regulatory and normative monitoring
- Risk analysis following ISO 14971 : AMDEC product (seriousness, probability, detection, method to reduce risk)
R&D tasks carried out:
- List of verification test for a preclinical assessment
- Study about chemical characterization of different products: GPC, FTIR, GC/MS, Gravimetric analysis
- Stability studies and writing protocols for real time and accelerated aging (shelf life determination)
- Writing protocols about mechanical testing for routine control
- Product and purchase specifications
Centre d'investigation clinique en innovations technologique
- Assistant ingénieur en R&D
2014 - 2014- Technical and functional specifications : requirement analysis, technical specification characterizations, FAST (Function Analysis System Technique) diagram
- Regulatory and normative monitoring
- Preliminary risk analysis following ISO 14971
- Chemical and mechanical studies of the product
- Computer aided design with SolidWorks 2014 to obtain a realistic representation of the device
Bordeaux2013 - 2015Master (Msc) biomatériaux et dispositifs médicaux
Medical devices analysis: Design approach, functional and technical needs, risk analysis
Regulatory: Technical file on class IIa, IIb and III medical devices (Classification, standards, risk analysis, conformity with the essential requirements of European directive 93/42/CEE), Quality approach, standards, European and international directives (USA, Canada, Brazil, CE marking)
