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.
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