Freelancer profile translated to English.
Back to original languageAbout Thomas
I firmly believe that regulatory compliance is not an administrative constraint, but a pillar of patient safety and industrial performance.
For over 10 years, I have been supporting medical device stakeholders — manufacturers, distributors, importers, and subcontractors — in their quality, regulatory strategy, and responsible innovation challenges.
My career path has led me from product development to the complete implementation of ISO 13485 quality systems, and to auditing for notified and certification bodies.
This dual field and regulatory experience allows me to bring a global, pragmatic, and results-oriented vision.
What motivates me: making regulation accessible, useful, and effective.
Because a quality system is only valuable if it truly improves practices and safety.
Because a medical device only makes sense if it is designed for the patient.
Based in Montpellier, I work in France and internationally, in person or remotely.
Always with the same conviction: regulatory rigor can (and must) be a driver of excellence.
French
Native or bilingual
English
Fluent
Can work on-site
Montpellier (up to 50km), Paris (up to 50km), Lyon (up to 50km), Nice (up to 50km), Toulouse (up to 50km)
Experience
- ISOFAC GROUPSenior Consultant QA/RA - MDR 2017/745 - ICA Auditor 13485MEDICALFebruary 2023 - Today (3 years and 4 months)Montpellier, France1. Quality Management• Design, deployment, and continuous improvement of Quality Management Systems• Compliance and alignment with FDA QSR• Conducting internal, supplier, and certification audits (ICA 13485 Auditor)• QA/RA transition management2. Regulatory Affairs• European and international regulatory compliance strategy for class I, Is, and IIa medical devices• Compilation and validation of technical files• Writing SAC/PSUR, PCVRR reports and post-market surveillance3. Clinical Evaluation & Scientific Documentation• Writing CEP and CER• Development and review of PMCF plans and reports• Critical review of scientific literature and analysis of clinical equivalence• Management and supervision of external service providers for clinical evaluation• Support for clinical investigations and documentary follow-up4. Risk Management• Complete development of the Risk Management File.• Validation of benefit/risk assessment methods.• Implementation of change control management and risk traceability5. Product Design & Development• Management of medical device design (DHF, DMR, DHR)• Writing and management of URS/SBU• Biological evaluation and usability assessment.• Technical specifications and product verification6. Validation & Process Control• Definition of qualification strategies for equipment and special processes and VSI• Support for sterilization process validation7. Audits, Assessments, and Certification• ICA ISO 13485:2016 Auditor: AFNOR Certification 0333• Product assessor for medical devices• Conducting independent audits and supporting CE marking8. Strategic Support & Transition Management• Overall management of MDR transition projects• QARA transition management in restructuring or structuring contexts
- Laboratoire AltheysQARA DirectorPHARMACEUTICALS INDUSTRYJanuary 2025 - October 2025 (9 months)Clermont-Ferrand, FranceOutsourced management of all Quality and Regulatory Affairs activities for the development and CE marking of a medical device (saline solution) under Regulation (EU) 2017/745.• Creation and deployment of the Quality Management System (QMS) under ISO 13485:2016 (procedures, work instructions, forms).• MDR project management• Structuring and writing the design dossier (DHF, DMR, DHR) and the Risk Management File (ISO 14971:2019).• Supervision of subcontracting for clinical evaluation and State-of-the-Art (SOTA), oversight of the PMCF plan and report.• Management of biological evaluation and demonstration of general safety and performance requirements.
- Essilor InstrumentsMedical Writer (Freelance)MEDICALMarch 2024 - July 2025 (1 year and 3 months)Créteil, France• Writing and updating clinical evaluation plans and reports (CEP / CER) in accordance with the MDR and MEDDEV 2.7/1 rev. 4 guide.• Writing the post-market clinical follow-up plan (PMCF Plan) and report.• Participation in clinical investigations: protocol review, documentary follow-up, and regulatory support.• Critical analysis of clinical and bibliographic data (systematic review, scientific literature, clinical equivalence).• Collaboration with R&D, regulatory affairs, and quality teams for consistency of technical documentation (Annexes II & III of the MDR).• Contribution to the clinical strategy and maintenance of product compliance within the ISO 13485 QMS framework.
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Education
- Master 2 (M2), Parcours Dispositif médicaux: de la conception à la commercialisationFaculté de pharmacie de Montpellier2019
- Master 2 (M2), Encadrement et coordination des services et des structures sanitairesFaculté de médecine de Montpellier2018
Certifications
- Internal Auditor Medical DevicesAFNOR Compétences2020
- SA30 Validation of MD Manufacturing Processes, MSPGMED2020