Description

After spending the first part of my career in Research and Education in life science, I have evolved internationally in the health industry from Research and Development roles in the biologicals sector, to positions in Regulatory Affairs/Quality Assurance and Production in the In Vitro Diagnostic (IVD) sector. Thus, I have acquired a practical understanding of the entire IVD sector allowing me for several years to support, as a Regulatory Consultant, IVD manufacturers and laboratories from different countries in their compliance projects.

My outgoing, logical and decisive nature, as well as my strategic approach, enables me to navigate from the bigger picture to the finer points.

At the heart of my approach lies a simple principle: your compliance, my focus.

Domaines d’expertise

Langues

Français
Bilingue ou natif
Anglais
Capacité professionnelle complète

Préférences en matière de lieu de travail

Accepte de travailler sur site

Tours (jusqu’à 50 km)

IVD REG
FOUNDER - IVD REGULATORY CONSULTANT
CONSEIL & AUDIT
septembre 2024 - Aujourd'hui (1 an et 9 mois)
Tours, France
Regulatory support for In Vitro Diagnostics (IVDs) and Laboratory Developed Tests (LDTs) / In-house IVDs
- Regulatory strategy for market entry – EU, US, Australia, other
- Full support for CE Marking
- Literature search
- Regulatory writing
- Full support for Performance Study Application in EU
- Regulatory compliance ongoing support
- Training
- Person Responsible for Regulatory Compliance (PRRC) for EU (Team PRRC member)
- IVDR 2017/746
- DIR 98/79/CE
- 21CFR
- Therapeutic Goods (Medical Devices) Regulations 2002
- ISO 13485
- ISO 14971
- ISO 20916
- ISO 23640
- ISO 62366
- CLSI guidelines
- ICH guidelines
Regulatory compliance ongoing support IVDR 2017/746 DIR 98/79/CE Regulatory writing IVDs
CENCORA Pharmalex
ASSOCIATE DIRECTOR – IVD REGULATORY CONSULTANT
CONSEIL & AUDIT
octobre 2021 - septembre 2024 (2 ans et 10 mois)
St Leonards, NSW, Australia
Regulatory support for In Vitro Diagnostics (IVDs) and Laboratory Developed Tests (LDTs) / In-house IVDs
- Regulatory strategy for market entry – EU, US, Australia, other
- Full support for CE Marking
- Literature search
- Regulatory writing
- Full support for Performance Study Application in EU
- Regulatory compliance ongoing support
- Training
- Audits
- IVDR 2017/746
- DIR 98/79/CE
- 21CFR
- Therapeutic Goods (Medical Devices) Regulations 2002
- ISO 13485
- ISO 14971
- ISO 20916
- ISO 23640
- ISO 62366
- CLSI guidelines
- ICH guidelines
Regulatory strategy for market entry – EU, US, Australia, other LTDs / In-house IVDs IVDR 2017/746 21CFR CDx
iV PASS
FOUNDER - IVD REGULATORY CONSULTANT
CONSEIL & AUDIT
juillet 2020 - octobre 2021 (1 an et 4 mois)
Anglet, France
Regulatory support for In Vitro Diagnostics (IVDs) and In-house IVDs
- Regulatory strategy for market entry – EU
- Full support for CE Marking
- Literature search
- Regulatory writing
- Training
- IVDR 2017/746
- DIR 98/79/CE
- ISO 13485
- ISO 14971
- ISO 20916
- ISO 23640
- ISO 62366
- CLSI guidelines
Regulatory strategy for market entry – EU IVDR 2017/746 DIR 98/79/CE IVDs Literature search