Job description
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.