Mantell Associates is partnered with a growing Medical Devices organisation in their search for a Regulatory Affairs Manager.

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Regulatory Affairs Manager - Responsibilities:

• Report to the Quality, Regulatory and Clinical Director

• Responsible for managing regulatory affairs throughout the product life cycle, from design to market monitoring

• Manage the Regulatory Affairs 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

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Regulatory Affairs Manager - Requirements:

• Higher scientific education (Bac+5)

• At least 6 years of experience in a Regulatory Affairs department in the field of Medical Devices

• Successful experience in Management

• Master the standards and regulations applicable to Medical Devices (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

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Mantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.