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.