Emmanuel Thomas
Head of Quality and Regulatory Affairs (Qara) @Robeauté
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WORK HISTORY
Head of Quality and Regulatory Affairs (Qara) @Robeauté
Paris, FR
EDUCATION
University of Montpellier
DEA (equivalent to Master)
Faculté de Pharmacie Paris XI
PhD
Ecole Nationale Superieure de Chimie de Montpellier
Engineer's degree
SKILLS
ABOUT EMMANUEL THOMAS
20 years\' experience dedicated to innovation for medical devices (class II and and drugs development. Cross-functional team leadership (>10 people). Proven ability to drive projects from Proof of Concept (PoC) to industrialization and commercialization. Instrumental in the development of API and Medical devices up to submission to the Regulatory Agencies (FDA, Notified Bodies). Strong expertise on Design Control, Regulatory, Quality and CMC Requirements. Effective communicator. Certified Auditor ISO 13485. Certified Lean Six Sigma Green Belt. Management & Leadership: • Multi-site cross-functional team management (>10 people). • Member of the Board of Directors, Involvement in Executive Committee strategic discussions. • Accountable for budget >1M€/year • Management of multiple critical subcontractors. Regulatory Affairs: • Design of submission strategies for US and Europe. • Writing of Technical Dossier for CE mark and FDA submissions (510k, de Novo, IDE/PMA). • Regulatory Watch. • Member of ISO committee ISO/TC194 Biological Evaluation of Medical Devices, ISO 10993. • Leadership to address responses to submission deficiencies. • Many interactions (written and oral) with FDA and Notified Bodies, Audits. Quality • Strong knowledge of ISO 13485, 21 CFR Part 820, MDR, ISO 14971, ISO 62366, ISO 10993, cGMP, ICH. • Instrumental in setting up QMS. • Management of the QC Department. • Lead Auditor ISO 13485. • Intensive CAPA, NC/OOS, Change controls experience. Development: • Design and Development of Medical Devices and APIs. • Design Control strategy, Risk Management per ISO 14971. • Safety and Performance assessment. • Design of VnV activities. • Expert in Stability studies, Transport & Shelf-life, Degradation studies, Biocompatibilty per ISO 10993 (Expert Chemical Characterization). • Management of industrialization and transfer to manufacturing sites. • Strong expertise in sterile products. • Validation of Manufacturing processes. CMC: • Proficiency in organic chemistry (polymers, small molecules, APIs) • Process Design/Optimization, Scale-up • Quality by Design (QbD) concept and DOE. • Lean Manufacturing. • Expert Analytics (HPLC, NMR, FTIR, GC, Instron, SEM, …)#Medical Devices #CMC #Regulatoryaffairs #Quality #Development #API
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