Regulatory Affairs Manager - Medical Devices

Posted 01 May 2024
Salary Negotiable
Job type Full Time
Discipline Medical Devices
Contact NameSharleney Chandraratna

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.