Freelancer profile translated to English.
Back to original languageAbout Jonathan
In my opinion, only a quality approach aligned with real operational constraints, built hand in hand with manufacturers, can ensure effective integration of quality processes and build a sustainable and efficient strategy. I put my expertise at the service of companies wishing to guarantee the regulatory compliance and operational excellence of their health products.
With a scientific background, I eventually specialized in quality assurance and regulatory affairs in the medical device industry. My approach is structured, educational, and results-oriented. I enjoy bridging the gap between regulatory requirements and industrial realities to build pragmatic, sustainable, and integrated quality systems.
French
Native or bilingual
English
Fluent
German
Conversational
Remote only
Primarily works remotely
Experience
- IntrasenseQuality ManagerMarch 2024 - June 2025 (1 year and 3 months)Montpellier, FranceQuality Assurance (system)• Responsible for managing the takeover of the quality management system and compliance with applicable requirements• Monitor QMS activities as planned• Contributing to compliance with new medical regulations• Leading management reviews• Preparing for and taking part in audits (External/internal/supplier)regulatory guidelines and act as an objective reviewer to examine the documents and ensure that product development complies regulatory guidelines.• Review project deliverables, such as design verification and validation reports.• Participate in usability and risk management activities.• Participate in the preparation of the regulatory submission.• Supporting post-marketing activities where necessary, such as corrective and preventive action projects related to identified design issues, assistance with root cause analysis, CAPA preparation, complaints and risk assessment of distributed products.
- IntrasenseSenior AQ EngineerMEDICALOctober 2022 - March 2024 (1 year and 5 months)Montpellier, FranceResponsible for managing the takeover of the quality management system and compliance with applicable requirements• Monitor QMS activities as planned• Contributing to compliance with new medical regulations• Leading management reviews• Preparing for and taking part in audits (External/internal/supplier)regulatory guidelines and act as an objective reviewer to examine the documents and ensure that product development complies regulatory guidelines.• Review project deliverables, such as design verification and validation reports.• Participate in usability and risk management activities.• Participate in the preparation of the regulatory submission.• Supporting post-marketing activities where necessary, such as corrective and preventive action projects related to identified design issues, assistance with root cause analysis, CAPA preparation, complaints and risk assessment of distributed products.
- Int'Air MedicalDeputy Manager Quality AssuranceJanuary 2020 - September 2022 (2 years and 8 months)Ain, France• Review, update and improve "Customer Complaint" procedure• Analyze customer complaints• Lead "Customer Complaints" meetings to determine the root cause and shape the action plan• Manage CAPA progress regarding non-compliancies and write CAPA updates• Share to customers the issue causes and implemented corrective actions• Follow-up of Medical Device Vigilance files in association with the QR/RA Manager• Update and analyze quality KPI• Coordinate supplier selection and qualification• Participate to purchase contracts drafting• Draft supplier technical and quality specification and ensure they are respected• Handle changes requested by suppliers• Assess suppliers• Carry supplier audits and monitor their corrective action implementation• Issue supplier non-compliancies and monitor their corrective action implementation• Supervise and coordinate AQ team activities : 6 members• Assist Direction as part of the steering process and into QMS monitoring and surveillance: non-conformities, customer complaints, internal and third parts audits, CAPA, KPI, etc., in collaboration with the QA/RA Manager• Carry internal and external audits
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Education
- FDA regulation 21CFR820 and ISO 13485 Medical Device Quality and Regulatory Affairs Building its quality management system ISO 13485 Risk management for medical devices according to the standardFDA regulation 21CFR820 and ISO 13485 Responsable Qualité et affaires réglementaires Dispositifs Médicaux Construire son système de management de la qualité ISO 13485 La gestion des risques pour les dispositifs médicaux selon la norme
- Master 2 (M2)University of Montpellier2018Master 2 (M2)