Description

En tant que consultant indépendant en affaires réglementaires et qualité, j'accompagne les fabricants de dispositifs médicaux dans l'obtention et le maintien du marquage CE conformément au Règlement (UE) 2017/745.

Mon expertise comprend la mise en œuvre de systèmes de gestion de la qualité conformes à la norme ISO 13485, la préparation de la documentation technique, la gestion des risques et la garantie de la conformité réglementaire.

Je possède également de solides compétences en rédaction médicale, ayant rédigé plus de 40 documents réglementaires, dont des rapports d'évaluation clinique (REC), des plans PMS/PMCF et des justifications techniques.

J'ai récemment mené à bien le marquage CE d'un dispositif stérile de classe IIa, supervisant l'ensemble des activités réglementaires et qualité.

Je suis disponible pour des missions en freelance dans toute l'Europe, à distance et sur site.

Industry field of expertise

Languages

English
Native or bilingual
French
Native or bilingual

Workplace preferences

Can work on-site

Paris (up to 50km), Lyon (up to 50km), Annecy (up to 50km)

A2M
Quality and regulatory affairs consultant
January 2019 - Today (7 years and 5 months)
CE marking & ISO 13485 certificate obtained in 2025, May

• Deployment of a QMS in compliance with ISO 13485:2016 (procedures, training, audits, management review)
• Preparation of Technical Documentation per Regulation (EU) 2017/745
• Oversight of design and development documentation (inputs, outputs, verification, validation, transfer)
• Drafting of IFU and labeling compliant with ISO 15223-1 and MDR
• Risk Management implementation (ISO 14971)
• Preclinical plan/report drafting: biocompatibility, sterilization, usability, aging, performance tests
• Clinical Evaluation based on literature route (Annex XIV & MDCG 2020-5)
• Process validation: IQ/OQ/PQ protocols, reports, and sampling plans
• PMS and PMCF Plans in line with MDR and MDCG 2022-21
• Supplier management: quality agreements, specs, audits, monitoring
• UDI implementation and EUDAMED registration
- Participation in Notified Body audits and technical file review
ISO 13485 MDR 2017/745 Recherche et développement R&D Management de la qualité affaires réglementaires
Camille Roy,
Medical writer
May 2017 - Today (9 years and 1 month)
OVER 25 clinical evaluation reports validated by notified body for 15 manufacturers
Preparation of CLINICAL EVALUATION REPORTS FOR ORTHOPEDIC PROSTHESES (hips, knee, spine, etc.) of class III and II-b ultrasound systems through the review of the 2017, May literature according to the Meddev 2.7 / 1 rev.4 guide and MDCG 2020-5
Biocorp
Regulatory Affairs Consultant – FDA 510(k) Submission
January 2021 - December 2024 (3 years and 11 months)
63500 Issoire, France
FDA 510(k) clearance obtained in 2022
• Expertise in design control
• Supporting the R&D team in reviewing or detailing some of the information to answer FDA's feedback
• Participation in the 510k file updating in order to obtain clearance
• Review and update of the entire risk management file in accordance with FDA
2021, July requirements