Geneva, Geneva, Switzerland
I thrive at the intersection of healthcare innovation and quality, transforming complex challenges into impactful solutions. With deep expertise in medical device development, regulatory compliance (ISO 13485, MDR, FDA), and risk management. I ensure cutting-edge technologies reach patients safely and effectively. I excel in multidisciplinary collaborations, optimizing quality systems, supporting clinical investigations, and driving compliance without compromising innovation. Key Competences: Leadership & Team Management / Medical Device Development / Quality & Regulatory Compliance / Risk Management & Failure Analysis / Technical Documentation & Audits
▶ Provide clinical and technical support during complex neurovascular endovascular procedures, delivering case coverage and procedural guidance to ensure safe, effective device utilization and successful therapy adoption. ▶ Educate and train physicians, nurses, and cathlab teams on product use, clinical best practices, and innovative technologies to optimize procedural outcomes. ▶ Build and maintain strong relationships with key opinion leaders (KOLs), investigators and multidisciplinary hospital teams. ▶ Collaborate cross-functionally with R&D, Clinical Affairs, Medical Affairs, Marketing and Commercial teams to translate clinical insights into product improvements. ▶ Support product evaluations, clinical studies, Site Initiation Visits (SIVs) and new product launches. ▶ Maintain clinical trial documentation (ISF/TMF) and ensure compliance with ICH-GCP, ISO 14155 and applicable regulatory requirements. ▶ Manage clinical data within Electronic Data Capture (EDC) systems, including eCRF completion, data review and query resolution. ▶ Ensure compliance with quality standards while promoting patient safety and clinical excellence.
▶ Developed and implemented quality assurance strategies, ensuring compliance with regulatory standards and product excellence. ▶ Led cross-functional quality teams in software QA, design control, manufacturing support, and risk management. ▶ Managed performance appraisal, and professional development. ▶ Reviewed and analyzed project and customer requirements, ensuring alignment with industry regulations and company procedures. ▶ Led quality input on CAPA & NC investigations, implementing corrective actions to enhance product quality. ▶ Collected and analyzed process metrics, identifying key areas for efficiency gains. ▶ Supported clinical investigations preparation, including Site Initiation Visits (SIVs).
▶ Directed multidisciplinary teams in the development of Class III implantable medical devices (bioartificial pancreas). ▶ Defined user requirements through collaborations with surgeons, Key Opinion Leaders (KOLs), nurses and patients. ▶ Spearheaded regulatory strategy, managing Notified Body selection and Competent Authority interactions. ▶ Oversaw preclinical evaluations, covering sterile barrier system, sterilization, shipping conditions validation and biocompatibility. ▶ Led cadaveric and porcine surgical evaluations, training surgeons on implantation procedures, collecting usability feedback, and translating clinical observations into product design improvements. ▶ Led risk management initiatives, ensuring compliance with ISO 14971, ISO/TR 24971 and IEC 62366. ▶ Managed design control and technical documentation (DHF, DHR, DMR), ensuring audit readiness and traceability. ▶ Secured competent authority approval by contributing to Clinical Trial Authorization (CTA) documentation, enabling clinical trial progression. ▶ Performed competitive and technological analysis. ▶ Drafted patents and Soleau envelopes. ▶ Supervised QMS and regulatory affairs.
▶ Applied and ensured compliance with relevant regulations, including MDD 93/42/EC, MDR 2017/745, Regulations 722/2012 and 1394/2007. ▶ Classified products as medical devices or advanced therapy medicinal products. ▶ Defined conformity assessment procedures and identified applicable essential requirements. ▶ Assessed and implemented relevant compliance standards. ▶ Conducted regulatory and normative monitoring to maintain up-to-date compliance. ▶ Liaised with regulatory authorities (FAMHP, ANSM, FDA) to support approvals and compliance. ▶ Managed and drafted documentation for scientific advice submissions to competent authorities. ▶ Led the selection process for the Notified Body. ▶ Conducted internal audits to ensure regulatory and quality compliance. ▶ Implemented, maintained, and secured certification for quality systems (ISO 13485, ISO 9001). ▶ Coordinated risk management in alignment with ISO 14971 and IEC 62366.
November 2015 (Paris, France): Speaker at IFSBM symposium : Regulatory aspects for the development of the bioartificial pancreas February 2015 (Munich, Germany): Speaker at "Clinical Operations & Outsourcing": The Bioartificial Pancreas Route to clinics September 2014 (Besançon, France): Speaker at "la rentrée du Dispositif Médical": Strategy to demonstrate the clinical evidence for borderline products
Place des polymères et biopolymères dans le domaine de la santé et des dispositifs médicaux, une vision industrielle.
Regulatory lectures about medical devices, combined products and advanced therapies medicinal products