From 2018 ABISS : Technical Manager Location : 14 rue de la télématique 42000 St EtienneProlapse meshes, stress incontinence slings, trocar for cancer surgery, parietal meshesSKILLS :Regulatory Affairs :CE Technical files for Medical devices (class I to III) according to MDD and MDRIFUsTechnical product specifications Product Risk management, essential requirements checklistProduct performances summary, product validation and verificationPackaging studies according to applicable standardsShelf life and lifetime studies, development of associated modelsPost marketing studies, PMCF clinical documentationBiological assessment protocols and reportsUsability testing and reportsQuality Assurance / Process Validations :Manufacturing instructions for operators and associated in-process controls and methodsSupplying specifications for subcontractorsStatistical Process control (SPC) Process risk evaluations (FMEA) and process validationsMaster validation plan Qualification of OperatorsProtocols and reports for process and product validations ; process risks management : IQ, OQ, PQTesting method qualificationsResearch & Development :Design of experiment (DOE)Testing results simulations,Testing methods development (internal and external laboratories)Management of R&D teams ;Preclinical testing (class I to III devices) : microbiology, biocompatibility and chemical testingsChemical caracterisations, biological risk assessmentBuilding of design teams (with clinical experts, engineers, distributors … ) in France, Italy,Spain, US, China, South Africa, South America…Design validation, verification and reviews ; Design files according to European and USRequirements Clinical evaluation (CER) according to applicable MEDDEV guidelines (2.7/1)Patents writing (Europe, US)Management : More than 20 years.R&D projects, Process validation committee, Clinical evaluation Files, Design files according to regulations EU 2017/745 and 21 CFR part 820

2005–2018 ASPIDE MEDICAL : Technical ManagerMedical devices : hernia meshes, fixation device, anchors, vascular device for oncology, gastric band, ancillaries, aesthetic surgeriesLocation : Allée Lavoisier, 42350 La Talaudière - France70 peopleTurn over : 9 M€Design of meshes and medical devices in polypropylene, polyester or absorbable materials(polylactic acid, collagen, chitosan…)Design of new productsDesign of a rectal trocar for the treatment of tumors, of a gastric ring, a vascular access systemManagement of Projects for aesthetic surgeries : eg. breast ptosis implants.Design file building, development of the manufacturing processes and testing methods.CE technical file writing ; Clinical evaluation reports for all the ranges of productsManagement of 3 engineers ; R&D projects management ; reporting to CEO.Post marketing surveillance reports : review of non conformities and surveillance websites.Corrective and preventive actions follow up.Member of the directive Board.

1997 – 2004 – BARD France (Cardial) : R&D ManagerLocation : 28 rue de la Télématique 42000 Saint Etienne - France55 people ; Turn over : 2 M€Vascular implantable class III products with collagen or polysaccharide coatings ;Design of products and processes ; Member of the Statistical Process Control and Processvalidation team.Optimization of the physical, mechanical and biochemical testing methodsManagement of 3 people.