Consultant Affaires Règlementaires des dispositifs médicaux

Références

August2023 – November 2024: 15 months, Medical Devices Promotion Compliance Consultant at GUERBET
✓ Validation of promotional and non-promotional materials related to medical devices (website, banner, emailing, posts, etc…)
✓ Managing non-conformities of Compliance department
✓ Writing procedure of regulatory watch for compliance activities
✓ Writing gap analysis form to assess evolution of standards and regulation
✓ Training colleagues on regulation for promotion of medical devices

January2023 – June 2023: 6months, Regulatory Affairs Specialist Consultant at INTECH MEDICAL
✓ Updating Technical file of class Ir medical device for MDR compliance
✓ Writing GSPRs for MDR compliance
✓ Writing PMS Plan
✓ Writing Risk management Plan
✓ Writing procedure of regulatory monitoring intelligence
✓ Preparing registration of class Ir medical devices in UK

January2022 – December2022: 12 months, Regulatory Affairs Specialist Consultant at PRODIMED
✓ Managing and writing Risk management files of class IIa & III medical devices
✓ Managing non-conformities of technical files of class IIa, III medical devices
✓ Updating procedures of regulatory monitoring intelligence
✓ Performing gap analysis of new standards and guidelines
✓ Writing PMS reports (PSURs)
✓ Managing the realization of clinical evaluation report of class IIa & III medical devices with subcontractor ECLEVAR
✓ Discussing with subcontractor ECLEVAR for putting in place PMCF studies for class IIa and III medical devices
✓ Managing the realization of BRA of class I medical with subcontractor ICARE
June2021 – November 2021: 6 months, Regulatory Affairs Specialist Consultant at Groupe SEBBIN
✓ Writing PMS report for class IIB medical device (calf implant)
✓ Writing technical dossiers for registration in Egypt, Koweit, UAE
✓ Writing of Manufacturer incidents reports (MIR) for mammary implants for notification to CA
✓ Registration of materiovigilance in company database

October2020 – May 2021: 8 months, Regulatory Affairs Specialist Consultant at LABORATOIRES INNOTHERA
✓ Managing and writing Risk management dossiers of class I medical devices
✓ Writing of Usability engineering dossiers of class I medical devices according to NF EN 62366-1:2015
✓ Updating of Technical dossiers of class I medical devices in accordance with MDR 2017/745
✓ Writing and updating of procedures (risk management procedure, CE marking procedure, validation of promotional materials)
✓ Writing of medical dossier of products according to ISO 13485:2016
✓ Writing of a checking file of compliance to MDR 2017/745
✓ Training of colleagues on risk management process

January2020 - July: 7 months Regulatory Affairs Specialist Consultant at ITENA CLINICAL
✓ Advising in regulatory framework related to the transition from OBL status to Legal manufacturer
✓ Writing of technical dossiers of class IIA MD for CE Marked approval related to MDD 93/42/EEC
✓ Replying to non-conformities related to technical dossiers to Notified Body
✓ Participating to notified body’s audit for CE marked approval of dental products

August2019- December2019: 5 months Regulatory Affairs Specialist Consultant at VIVACY
✓ Registration of aesthetic products (class III MD) in Russia, Taiwan, Thailand
✓ Renewal of licenses of aesthetic products (class III MD) in Ukraine
✓ Gap analysis of Therapeutic Goods Advertising Code (No.2) 2018 related to Vivacy’s activities
✓ Analyzing of MDR guidelines related to EUDAMED, legacy devices, clinical equivalence, and clinical evidence
✓ Acquiring of Free Sale Certificates for aesthetic products
✓ Managing activities related to notarization, apostille and legalization of documents for registration
✓ Getting certified copies of documents for registration activities

January2019- July2019: 7 months Regulatory Affairs Specialist Consultant at MAUNA KEA TECHNOLOGIES
✓ Gap analysis of MDR 2017/745 related to medical devices (MD)
✓ Coordinate implementation of regulatory documents (PMS plan, Clinical evaluation plan, PSUR, etc.) for class IIA MD with
the view to be compliant to MDR 2017/745
✓ Support registrations activities for class IIA MD in Turkey
✓ Advice on regulatory activities

April2017- Dec.2018:20 months, Regulatory Affairs Specialist Consultant at JOHNSON & JOHNSON Group
✓ Ensure regulatory compliance of Medical Devices for their access to the French, Benelux and Nordics markets and follow-up
their life cycle
✓ Identify regulatory issues concerning Medical Devices, report them to the Senior RA Manager, investigate and suggest
solutions to resolve them
✓ Review and approve Medical Devices promotional materials
✓ Provide regulatory support (in collaboration with franchises and EMEA/US Regulatory Affairs) to marketing, sales
representatives & Tenders (product technical document, communication of regulatory documents and/or information, answer to
regulatory and technical questions on products…)
✓ Writing of the SCD of Class III and implantable MD according to the new French decree N° 2016-1716 of 13 Dec.2016
✓ Writing of Europharmat Technical File for Medical Devices
✓ Gathering regulatory data for a new software MDRIM designing for regulatory activities
✓ Utilizing MDRIM to manage regulatory activities related to NPD, NPI, changes on medical devices
✓ Gap analysis and improvement of Regulatory intelligence process according to EMEA procedure

May2016- March2017: 11 months, Regulatory Affairs Specialist Consultant at SANTEN Group
✓ Registration of ophthalmology class IIB medical device abroad (MENA, ASIA, CIS, Gulf countries, USA, Canada)
✓ Management of variations dossiers related to the modification on the technical dossier for the registration abroad
✓ Fulfill the regulatory database Trackwise
✓ Working on technical dossier for line extension of class IIB medical device for CE Mark approval
✓ Writing of new regulatory procedures for instance the SOP for the management of clinical trials, etc.
✓ Support to international subsidiaries and local correspondents

Oct.2014- March2016: 18 months, Quality & Regulatory Affairs Engineer at MEDICAL Group
✓ Extension of certification on the new plant of MEDICAL Group according to ISO 13485 (2012) standard
✓ Implementation of Master validation plan for different activities and products of the company
✓ Writing protocols (IQ, OQ, PQ) for validation of manufacturing process of bone substitutes
✓ Planning and carrying out qualification tests in the oven in high temperature with collaboration of Production service
✓ Collaboration with laboratory of control for planification and execution of control tests on samples (LAL test, Packaging seal
strength test, visual test)
✓ Writing of Technical dossiers for class III, I medical devices for CE Mark approval
✓ Renewal of EC certificates for class III, IIB, IIA, I medical devices
✓ Support for registration of products outside the European Union (MENA, Gulf countries)
✓ Legalization of documents for registration activities
✓ Acquiring of free sale certificates (FSC) of medical devices for registration activities

March- Sept.2014: 6 months, internship Engineer in Qualification & Validation of processes at MEDTRONIC
✓ Implementation of validation activities in collaboration with many departments of the site
✓ Elaboration of the validation strategy for the sealing process of medical devices
✓ Writing validation documents (IQ, OQ, PQ) with collaboration of Quality department
✓ Performing the calibration of machines in collaboration with a subcontractor
✓ Coordination of sterilization activities on samples in collaboration with a subcontractor
✓ Collaboration with laboratory of control for planification and execution of control tests on samples (Dye pen test, Packaging
seal strength test)
✓ Data analysis with Minitab and writing of validation reports

Etudes

2011-2014: Double Degree in Biomedical Engineering and Regulatory Affairs in Medical Devices of Polytech Lyon, UCBL

2007-2010: Bachelor Degree in Biomedical Engineering at University des montagnes