Françoise Cettour-Delbart

Experience

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  BD Diagnostics, Diagnostic Systems - Europe, Eastern Europe, Middle East and Africa

  Aug 1992 - Dec 2013

  - Pour soutenir la croissance du marché, sécurisation de la situation réglementaire des produits et des activités au sein de l’Union Européenne (marquage CE), ainsi que dans les pays d’Europe de l’Est, du Moyen Orient et de l’Afrique (enregistrements). - Mandataire pour les fabricants situés hors de l'UE.- Gestion de l’intégration réglementaire et qualité des sociétés rachetées- Qualification et suivi des sous-traitants (audits, gestion des interactions).- Réalisation d'audits qualité.- Gestions des processus qualité.- To sustain market growth, ensure the regulatory situation of BD Diagnostic Systems products and activities within the European Union region (CE marking) as well as the Eastern Europe, Middle East and Africa countries (registration).- EC representative for the manufacturers located outside of the EU.- Management of the regulatory and quality integration of acquired companies.- External suppliers qualification and follow up management (audits, primary contacts).- Performing quality audits.- Quality processes management. Show less - Gestion de la situation réglementaire des produits dans les pays ayant une réglementation au sein de l’Union Européenne (marquage CE), ainsi que dans les pays d’Europe Centrale et de l’Est, du Moyen Orient et de l’Afrique (enregistrement).- Mandataire pour les fabricants situés hors de l'UE.- Coordination des processus de rappels de lot, gestion des réclamations clients, vigilance.- Management of the regulatory situation of products within the European Union (CE marking), as well as the Central and Eastern Europe, Middle East and Africa countries (registration).- EC representative for the manufacturers located outside of the EU.- Coordination of recalls, customer complaint management, vigilance processes. Show less

  • Manager, Regulatory & Quality Management

    Oct 2004 - Dec 2013

  • Coordinator, Regulatory Compliance

    Oct 1994 - Sept 2004

  • Assistant, Regulatory Affairs

    Aug 1992 - Sept 1994
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  Regulatory & Quality Consultancy

  Jan 2014 - Jun 2014

  Executive Regulatory & Quality Consultant

  Impliqué dans l’industrie du DIV ou du DM?Intéressé par une expertise Réglementaire ou Qualité pour ou hors de l’Union Européenne pour développer plus loin la croissante de votre marché?Désireux d’explorer comment une ressource Réglementaire et Qualité peut aider à la réflexion stratégique et la prise de décisions éclairées, et ainsi atteindre des objectifs ambitieux ?Involved in the IVD or Medical Device industry?Interested in EU and non-EU Regulatory Affairs & Quality Systems expertize to further support your growing business?Want to explore how a comprehensive Quality & Regulatory resource can help strategic thinking and informed decision-making, and thus achieve ambitious goals? Show less

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  DePuy Synthes Companies

  Jan 2014 - Jan 2017

  RA
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  Amaris Technologies

  Jul 2014 - Mar 2017

  Senior Regulatory Consultant

  Conseil et support aux fabricants de dispositifs médicaux, au long de la vie des dispositifs, selon les exigences applicables des Directives concernant les dispositifs médicaux, par exemple- Gestion de l’évaluation des exigences réglementaires applicable aux fonctionnalités et au design- Coordination des risques de conception, de production et cliniques (analyse et évaluations des risques, maîtrise des risques, analyse risques/bénéfices, etc.)- Réalisation de la revue réglementaire de l’étiquetage- Gestion de la compilation et de la mise à jour des Dossiers Techniques et Dossiers de Conception- Support lors d'audits de l'Organisme Notifié- Gestion des aspects réglementaires lors de transfert de site de productionGuidance and support to medical device manufacturers, over devices life cycle, in line with the requirements of the applicable Medical Devices Directives, eg.- Functional and design regulatory requirements assessment management- Design, production and clinical risks management (risk analysis and evaluation, risk control measures, risk benefit analysis, etc.) coordination- Labeling regulatory review implementation- Technical File and Design Dossier creation and maintenance management- Notified Body audits support- Manufacturing site transfert regulatory management Show less

• 

  DePuy Synthes

  Apr 2017 - now

  MDR regulatory strategy readiness and execution support- Reshaping of RA owned procedures to efficiently address MDR specific developments- MDR technical documentation updates supportLife cycle management (patient safety, back order prevention or cost reduction) initiatives worldwide RA leadership- Worldwide RA leadership in the development and execution of an integrated and streamlined process for LCM changes (production site, manufacturing process or equipment, or design changes): from projects prioritization/feasibility assessment/planning to projects implementation monitoring- Accountable for all RA effort estimation, and resourcing of US and oUS projects based on priorityManagement and coaching of the PFT RA resources (4 members)- High performing, issue resolution driven, RA team building, to support the implementation of all Supply Chain initiativesRA team resource management facilitation- Contribute to an agile and efficient resourcing of projects, according to priorities and timelines, for an optimal RA resource utilization.- Lead tool enhancements for an efficient reporting to top managementProducts market access maintenance- Support Use As Is and other non-conformance related activities, ensuring compliance, securing patient safety, and minimizing backorder situationsSupport of internal and external (e.g. TÜV, MDSAP) auditsSkillful Notified Body collaboration, eg. for expedited Change Notifications (TÜV) approvals Show less New product development RA lead- Management of the regulatory strategy definition for priority geographies (EU, US, Canada): product classification, applicable requirements, etc.- Providing the cross-functional NPD team with innovative solutions and guidance towards all RA deliverables - Securing CE marking and 510(k) clearance (e.g. MatrixRIB Self-Drilling Screws cleared within 70 days with no significant FDA enquiry).- Shaping the most appropriate Supply Chain approach.Life cycle management (production site, manufacturing process or equipment, or design changes) RA leadership- Overall RA leadership in the development and execution of an integrated and streamlined process for LCM changes within the Product Focus Team (PFT) governance, o projects prioritization, planning and implementation o Time-To-Market approach- Accountable for the RA effort estimation and resourcing of projects- High performing RA team building, to support the implementation of Supply Chain initiativesRA team resource management- Drive smart tools development (e.g. advanced effort estimation tool, improved Qlik reports)- Contribute to an agile and efficient resourcing of projects, according to priorities and timelines, for an optimal RA resource utilization.MDR regulatory strategy readiness and execution support- Reshaping of RA owned procedures (e.g. DoC creation) to efficiently address MDR specific developments- MDR technical documentation updates, including post-market surveillance documents and labeling changesSupport of internal (JJRC) and external (e.g. TüV, MDSAP) audits Show less

  • Regulatory Affairs Manager – Established Products E2E

    Sept 2022 - now

  • Senior Regulatory Affairs Program Lead

    Apr 2017 - Aug 2022