Regulatory Affairs Manager - Medical Devices > Joboolo FR :
Société : Mantell Associates Lieu : Auvergne-Rhône-Alpes
MantellAssociates is partnered with a growing MedicalDevices organisation in their search for a RegulatoryAffairsManager.
RegulatoryAffairsManager - Responsibilities:
Report to the Quality, Regulatory and Clinical Director Responsible for managing regulatoryaffairs throughout the product life cycle, from design to market monitoring Manage the RegulatoryAffairs team and coordinate activities Ensure regulatory and standards monitoring of products distributed in Europe and internationally Identify the list of standards/regulations applicable to the activity and check that they are taken into account Ensure coordination of monitoring activities with other company functions Write CE Marking technical files and carry out marketing declarations Ensure that the Technical File is kept up to date Ensure post CE marking maintenance of RMF and usability files Manage the regulatory evaluation process of changes and their communication to the notified body/competent authorities Being a regulatory representative in the design process - propose and implement appropriate technical-regulatory strategies Manage the list of standards applied by product range Provide regulatory support for the entire Design process Draft regulatory registrations and ensure coordination with international correspondents Handle regulatory and technical questions from health authorities, following the submission of the registration file Ensure the monitoring and maintenance of licenses Manage file variations with international correspondents RegulatoryAffairsManager - Requirements:
Higher scientific education (Bac5) At least 6 years of experience in a RegulatoryAffairs department in the field of MedicalDevices Successful experience in Management Master the standards and regulations applicable to MedicalDevices (ISO 134-85; Directive 93/42 CEE, MDR 2017/745, etc.) Have a fluent level of English B2 level of French Master IT Tools (Office Automation) Willing to be on site flexibly MantellAssociates is a specialist Pharmaceutical and Life Sciences headhunting firm.
For more information on this role, please contact us at 44 (0)20 3854 7700.
