Experience

BIOSYNEX

• France
• Biotechnology Research
• 100 - 200 Employee

• International Regulatory Affairs Officer

  • Mar 2020 - Present

  - In charge of IVD technical file completion for CE marking - In charge on international registrations of IVD medical devices (worlwide: Brazil, Saudi Arabia, South Korea...) - IVDR reference people in Biosynex for compliance transition period. Very good knowledge in new regulations (MDR and IVDR) - Good knowledge in QMS (ISO 13485) risk management (ISO 14971). Update of related procedures. - Team leader in UDI compliance process. - In charge of IVD technical file completion for CE marking - In charge on international registrations of IVD medical devices (worlwide: Brazil, Saudi Arabia, South Korea...) - IVDR reference people in Biosynex for compliance transition period. Very good knowledge in new regulations (MDR and IVDR) - Good knowledge in QMS (ISO 13485) risk management (ISO 14971). Update of related procedures. - Team leader in UDI compliance process.



InfiniteVision Optics SAS

• Application and regulatory engineer

  • Oct 2016 - Feb 2020

  My tasks (RA/QA engineer):- Update and follow-up of the ISO 13485: 2016 certified quality management system- Participation in the CE dossier completion and obtention of the CE-mark for an implantable medical device- Normative and regulatory monitoring- Responsible for the labeling and the traceability.My tasks (Application engineer):- In charge of the interactions with the medical centers and surgeons- Training of surgeons for the use of an implantable medical device- Customer survey- Management of customer orders and inventory. Show less

• Quality Engineer internship

  • Apr 2016 - Sep 2016

  I actively participated in the development of the quality system of this start-up, audited and certified EN ISO 13485: 2016.My tasks:- Definition of the quality system processes and the quality manual- Drafting of procedures- Writing of the forms used to create quality system records- Writing of work instructions Good knowledge in quality assurance and in ISO 13485 standard.



Anglia Ruskin University

• United Kingdom
• Higher Education
• 700 & Above Employee

• R&D internship within the Medical Engineering Research Group

  • Jan 2016 - Apr 2016

  My research topic: FINITE ELEMENTS ANALYSIS OF THE CONTACT PRESSURE DISTRIBUTION IN THE KNEE JOINT AFTER ANTERIOR CRUCIATE LIGAMENT INJURY. I did an internship in the UK, within the Anglia Ruskin University. As part of the MERG team (Medical Engineering Research Group), I worked on the problem of osteoarthritis of the knee, which is a public health problem, particularly with the increase in obesity and the aging of the population. The MERG works closely with the New York Hospital for Special Surgery (HSS). This latter is at the forefront in the field of movement analysis and orthopedics. Regarding my research, HSS performed MRI sequences of several knees of cadavers, as well as in vitro experiments to measure the distribution of mechanical contacts in the tibial cartilage. Then, I modeled a knee from MRI sequences using segmentation, thanks to the user-friendly software Mimics (Materialise). Moreover, I created a solid geometry of this model on Catia before making a finite element model on Abaqus. Subsequently, this model was validated using data from in vitro experiments performed at HSS. The relative pressure and strength on the tibia cartilage was compared and a difference of less than 8% was found. A very interesting solution was found by the MERG to realistically reproduce the impact of the ligaments, which is usually an issue in this type of modelization. This finite element model, specific to one patient, can then be used to study the impact of an injury. I chose to study the impact of an anterior cruciate ligament elongation, which is a very common injury of the knee, on the contact pressure distribution. The second part of the reflection was a discussion about the interest of a reconstructive surgery of the ligament using the finite elements model results. Show less



Biotika®

• France
• Research Services
• 1 - 100 Employee

• Purchasing, Supplier Quality Assurance & Marketing Manager

  • Sep 2015 - Dec 2015

  I was responsible for purchasing within Biotika, as well as supplier quality assurance.I actively participated in the continuous improvement of the quality system of Biotika by proposing modifications of procedures and forms.Skills and abilities developed: organization, order management, inventory management, supplier management, communication with all partners of the company.I was also responsible for the marketing/communication of the company.Example of a marketing mission: Presentation of Biotika and its projects to students of ESC Dijon in the idea of ​​a partnership between our company and their school.Skills and abilities developed: communication skills, fluency, ability to summarize and explain essential ideas. Show less

• Ingénieur R&D

  • Mar 2015 - Sep 2015

  J'ai travaillé sur un dispositif visant à réduire les risques de récidives des cicatrices chéloïdes après exérèse chirurgicale.Mes missions :- veille concurrentielle - rédaction du protocole d'essai clinique soumis au CPP- dialogue avec les postes transversauxBiotika étant une entreprise certifiée ISO 13485 par le LNE GMED depuis 2012, j'ai une bonne connaissance de cette norme et de l'importance du SMQ au sein d'une entreprise.



Solution Réussite

• Besançon, France

• Private tuition for home-based education

  • Dec 2014 - Dec 2015

  I did tutoring in life sciences and mathematics for high school students. Skills developed: patience, listening, communication. I did tutoring in life sciences and mathematics for high school students. Skills developed: patience, listening, communication.



Super U

• Eschau

• Employée commerciale

  • Jul 2015 - Aug 2015

  Depuis mes 18 ans et jusqu'à la fin de mes études, j'ai travaillé tous les étés au sein du super U d'Eschau, rayon BVP (Boulangerie, Viennoiserie et Pâtisserie). Dynamique, cela m'a notamment permis de découvrir le monde du travail. Missions : vente des produits aux clients, mise en rayon, tenue du rayon, tenue d'une caisse, gestion des stocks et des commandes... Compétences et aptitudes développées : esprit de vente, sens de la communication, relation avec les clients, tenue d'une caisse, gestion, solidarité Show less



CHRU Besançon

• Région de Besançon, France

• Stagiaire dans le service de Médecine nucléaire

  • Jan 2015 - Mar 2015

  Stage au sein du Centre Hospitalier Régional Universitaire de Besançon, dans le service de Médecine nucléaire. Mes missions : - Découverte du fonctionnement d'un service de centre hospitalier - Recherches bibliographiques pour établir un état de l'art sur l'utilisation des nouveaux médicaments radiopharmaceutiques en TEP : travail exclusivement en anglais via des publications scientifiques - Élaboration de protocoles pour l'utilisation de nouveaux médicaments radiopharmaceutiques en TEP, afin de faciliter leur utilisation en routine au sein du CHRU de Besançon. Show less



Herbapac

• Illkirch-Graffenstaden

• Employée

  • Aug 2014 - Aug 2014

  Job d'été au sein d'une entreprise de conditionnement de thé. Travail sur chaine de production. Aptitudes développées : esprit d'équipe, résistance au stress, rapidité de travail Job d'été au sein d'une entreprise de conditionnement de thé. Travail sur chaine de production. Aptitudes développées : esprit d'équipe, résistance au stress, rapidité de travail



FLENDER GRAFFENSTADEN

• Stagiaire au bureau d'études

  • Jul 2014 - Jul 2014

  Stage au sein du bureau d'études de l'entreprise Flender (groupe Siemens). Mes missions : - Mise en place de standards pour l'élaboration des schémas de câblage, afin d'en améliorer la qualité - Utilisation du logiciel Creo (anciennement Pro/E) - Dialogue avec les partenaires de l'entreprise Compétences et aptitudes développées : écoute, sens de la communication, maitrise du SMQ Stage au sein du bureau d'études de l'entreprise Flender (groupe Siemens). Mes missions : - Mise en place de standards pour l'élaboration des schémas de câblage, afin d'en améliorer la qualité - Utilisation du logiciel Creo (anciennement Pro/E) - Dialogue avec les partenaires de l'entreprise Compétences et aptitudes développées : écoute, sens de la communication, maitrise du SMQ