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.

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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

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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.