Fabienne Mathies

FABIENNE MATHIES Quality Assurance and Regulatory Affairs Director /Senior QARA Consultant PROFESSIONAL PROFILE MEDICAL DEVICE SPECIALIST: 20 years of experience in quality assurance and regulatory affairs CAREER SKILLS European regulations: Regulation (EU) 2017/745 (MDR) Directive 93/42/EEC (MDD) Quality standards: ISO 13485 & ISO 9001, 21CFR Part 820 Product standards: ISO 14971, IEC 62366, IEC 62304, IEC 60601-1, IEC-, IEC-, EN 14885, EN 16442, ISO 15883-1&4, , EN 14607, EN 14630 PRRC Materiovigilance Internal/External Auditor IT: Office Pack, MatrixReq Notion ERP Sylob 5, 4D QARA CONSULTANT ROCAMED - QARA Expert 01/2025 – 07/2025 Design, manufacture and marketing of implantable / non-implantable, sterile / non-sterile, single-use medical devices. Support to QARA Team of the company in MDR transition, certification audits, constitution of technical documentations, QMS major changes management, Production transfer PROMEPLA - Director QARA- DM Class Is, IIa and IIb 05/2024 - 01/2025 Design, manufacture and marketing of implantable / non-implantable, sterile / non-sterile, single-use medical devices. - Management of the QARA team (11 people) - Renewal of ISO 13485 certification - FDA inspection - CE marking under MDR with 2 notified bodies (rounds of questions and site audits) - QMS management, identification of necessary QMS improvements - RA support (risk management, old regulations, labelling, IFU, implementation of MDR customer contracts, etc.) - Management of marketing authorizations in EMEA, US, Canada, Asia and South America) - PRRC GC Aesthetics - Director RA- Implantable DM Class IIb and III 09/2023 - 04/2024 LANGUAGES English Upper Intermediate (B2) Design, manufacture and distribution of breast and body implants, associated sizing devices and tissue expansion devices. - Management of the RA team (6 people, FR and UK sites) - CE marking under MDR with 2 notified bodies (drafting and submission of DTs, transition management, new product) - Design support (risk management, old regulations, labelling, IFU, etc.) - Management of marketing authorisations for EMEA, APAC, LATAM) - PRRC QARA DIRECTOR TECHNO CONCEPT - Manosque 08/2019 – 08/2023 Design, manufacture and marketing of electromedical solutions for functional and postural rehabilitation ● Establishment, animation and maintenance of the effectiveness of the QMS; Process management, management review and process monitoring . ● ● ● ● ● ● ● ● ● ● ● ● ● committee, definition of indicators, customer satisfaction survey, implementation of corrective and preventive actions Bilingual (FR/EN) constitution and management of EC technical documentation according to RDM and QMS documentation Support for the development of new products in design Managing the design change process for existing products EUDAMED Data Management Preparation of marketing authorisation dossiers Supplier quality management (drafting of quality plans, specifications, definition and monitoring of performance indicators) Management of non-conformities and customer complaints, CAPA definition Implementation of the QMS software validation process Validation of manufacturing procedures and associated control ranges Internal / supplier and ON audits Creation and maintenance of MD risk management records throughout their life cycle (design, production, sales and post-marketing) according to ISO 14971, IEC 62366 National and international normative and regulatory monitoring Collection of post-market surveillance data and updating of PMS/PSUR records (by class) Quality and Regulatory Manager SOLUSCOPE - Aubagne 03/2010 - 08/2019 ● Design, manufacture, marketing and after-sales service (FR and export) of endoscope washer-disinfectors (LDE) and associated chemicals (detergents and disinfectants),endoscope storage cabinets (ESET) and traceability solutions Quality Manager After-sales service | SOLUSCOPE – Marseille 09/2007 - 02/2010 Quality Assistant SOLUSCOPE - Marseille 09/2005 - 03/2010 Physical Measurement Technician C.E.A, Cadarache, Microwave Laboratory 09/2002 - 08/2004 Quality Control Manager STSM - Le Genest-Saint-Isle 09/2001 - 07/2002 FORMATION Master : Quality System Manager - IFOCOP Marseille Mention Very good DUT : Physical measurements, instrumentation IUT of Saint-Nazaire - Saint-Nazaire Baccalaureate S : Physics Chemistry Lycée La Mennais - Ploërmel