Regulatory Affairs Manager - Medical Devices

Posted 08 July 2024
Salary Negotiable
Job type Full Time
Discipline Medical Devices
Contact NameSiobhan Mcloughlin

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.