Regulatory Affairs Manager, Export - Medical Devices

Posted 04 July 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, searching for a Regulatory Affairs Manager to participate in the registration/renewal and modifications of export products.

Regulatory Affairs Manager - Responsibilities:

  • Report to the International Registration Manager

  • You will be in charge of all products for a given geographic area

  • Draft regulatory registration/renewal/modification files and ensure coordination with international correspondents

  • Handle technical questions from health authorities

  • Participate in Change Control (analysis of export impact, opening of exchange rates, etc.)

  • Participate in updating technical files, in connection with export registrations (country specificity)

  • Advise and assist the departments concerned on export regulatory aspects (sales, production, labelling, etc.)

  • Be a force for proposals on regulatory strategy (product classification, country constraints)

  • Participate in regulatory monitoring (analysis of new regulations or changes to export regulations, etc.)

Regulatory Affairs Manager - Requirements:

  • Higher scientific education (Bas+5)

  • Minimum experience of 1 year within a Regulatory Affairs export department

  • Fluent in English

  • B2 level of French

  • 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.