Freelancer profile translated to English.
Back to original languageAbout Kévin
Pharmacist & Quality Assurance and Regulatory Affairs Consultant
Since 2021, I have been assisting start-ups and SMEs developing medical devices in securing their compliance:
Quality: ISO 13485, IEC 62304, ISO 14971, GMP
Regulatory: MDR, FDA 21 CFR Part 820, AI Act
Data & GDPR: DPIA, processing register, HDS, privacy policies
- Some achievements:
Deepsen (Lyon): complete restructuring of the ISO 13485 QMS and quality coaching
Téra One: creation and management of a health-at-work software (AI & GDPR by design)
Synergiphar (Boulogne-Billancourt): optimization of GDP / supply chain procedures
Solence: creation of the GDPR pack + CE technical file for an AI MD
- What I offer you:
Flash Audit 48h – €499 incl. tax
Express mapping of your risks (Quality, GDPR, Regulatory) + prioritized action plan
Tailor-made support (Daily rate €400)
Implementation or redesign of your QMS, creation of the CE/FDA file, AI/AI Act strategy
Team training & coaching
Mastery of ISO 13485/MDR requirements
QARA best practices
Areas of operation
France ‧ Benelux ‧ Switzerland ‧
Let's transform your regulatory constraints into real performance levers!
French
Native or bilingual
English
Conversational
Can work on-site
Paris (up to 50km), Lyon (up to 50km), Rouen (up to 50km), Lille (up to 50km), Tours (up to 50km)
Experience
- FractalQ Care
On Malt
MDR Compliance of an AI Medical Imaging SoftwareNovember 2025 - November 2025Paris, FranceRegulatory scoping and techno-regulatory assistance for the implementation of an AI-assisted radiology SaMD - Glentera SASe-Health ConsultantMEDICALDecember 2023 - Today (2 years and 6 months)Paris, France📍Innovation in health – AI, GDPR, QARA and hardware-software solutions.✅ Téra One – Health at work software• Design and management of an innovative software to digitize occupational medicine.• Development of AI-integrated features to automate medical and administrative processes.• GDPR compliance (impact analysis, consents, processing register).• Support for healthcare professionals for optimal adoption of digital tools.✅ Deepsen Mission (Lyon) – HealthTech• Structuring and optimization of the Quality Management System (QMS).• Audit execution and implementation of an action plan to ensure compliance with ISO 13485 standards.• Reorganization of the QMS architecture and revision of existing procedures.• Training of an intern in quality best practices and regulatory documentation.✅ Synergiphar SAS Mission (Boulogne-Billancourt) – Pharmaceutical distribution• Quality and regulatory affairs support for a pharmaceutical distribution company.• Review and optimization of quality procedures related to the supply chain and regulatory compliance.• Support for maintaining compliance of activities according to Good Distribution Practice (GDP) standards.✅ e-Health Consulting & Support• Strategic consulting for digital health projects (MVP, AI assistants, automation).• Team training on AI and health regulation issues (GDPR, HDS).• e-Health project management and coordination of technological partnerships.
- Solence,Junior Quality and Regulatory Affairs ManagerApril 2023 - March 2024 (11 months)Paris, France💡 Quality assurance and regulatory compliance support for e-health solutions✅ Medical Device Quality Assurance:• Implementation and optimization of quality systems (ISO 13485, IEC 62304).• Management of health data and CNIL compliance (creation of the GDPR pack: DPIA, processing register, consents).• Writing and updating QMS documentation• Preparation and participation in quality audits and inspections.• Management of cross-functional quality projects for digital medical devices.✅ Medical Device Regulatory Affairs:• Compliance with European and international regulations (MDR, FDA 21 CFR part 820).• Compilation and submission of technical documentation for CE marking.• Risk management according to ISO 14971 (RMF).• Review of regulatory files (specifications, classification).• Coordination with notified bodies and participation in clinical studies.
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Education
- Specialized Master in Health Industry Management - Regulatory AffairsIMIS Lyon,2023Master spécialisé en Management des Industries de Santé - Affaires Réglementaires
- Doctorate in PharmacyUniversity of Yaoundé 12021Cycle de development des produits de santé Assurance qualité des produits de santé Affaires réglementaires des produits de santé Normes et Réglementation en santé Propriété industrielle en santé