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

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

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

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.