Regulatory Affairs Manager

Role: Regulatory Affairs Manager

Location: France, Archamps

Company: Cosmetic Medical Device Company 

Duration: Permanent 

Reporting to the Quality, Regulatory and Clinical Director, you will be responsible for managing Regulatory Affairs throughout the product life cycle, from design to market monitoring. 

Responsibilities: 

• Manage the Regulatory Affairs team and coordinate activities:
• Ensure regulatory and standards monitoring:
• Ensure regulatory and standards monitoring of products distributed in Europe and internationally 
• Identify the list of standards/regulations applicable to the company's activity and check that they are taken into account
• Ensure coordination of monitoring activities with other company functions
• Manage CE Marking files: 
• 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
• Manage export records:
• 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

Requirements:

• Minimum 5 years of experience in Regulatory Affairs, specifically with Medical Devices
• Minimum 5 years of experience in successful team management
• Ideally experience with Class llb and lll Medical Devices
• Master the standards and regulations applicable to Medical Devices (ISO 134-85; Directive 93/42 CEE, MDR 2017/745, etc.)
• Fluent in English & French 
• Willing to be on site flexibly