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SCIENCEMD : Medical Device Regulatory & Clinical Evaluation/Claims Expert - L'oral France

CDI
Levallois-Perret
Salaire : Non spécifié
Télétravail fréquent
Expérience : > 5 ans

L'Oréal France
L'Oréal France

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Le poste

Descriptif du poste

The candidate will be within the MD Dedicated structure ScienceMD in charge of: 

MD Regulatory Project Management  

In charge of the project planning (schedule & cost) from day 1 with continuous versioning during the whole life cycle, in order to achieve regulatory compliance 

Coordinate experts and activities of the different entities of the Group involved in the development and commercialization of MD to ensure regulatory & quality compliance and with respect to cost and timing 

Ensure that activities are well documented from day 1 with continuous versioning during the whole life cycle according to MD Regulation and Quality requirements 

Interact with Legal Manufacturers to align L’Oréal activities with regulatory and legal manufacturer requirements 

Identifies and alerts any potential bottleneck  

MD Expertise 

Define the global MD regulatory strategy and possible pathways to market (mainly EU, US and China) 

Contribute to the project team for MD regulatory expertise during the whole life cycle 

Support the DMIs in the definition of the claims 

Contribute to the Clinical Evaluation Plan with respect to the intended use and the claims 

Provide guidance and support the conduction of clinical studies according to MD standards


Profil recherché

Scientific background e.g. PhD, pharmacist or equivalent, Life Science engineer… 

Strong technical competency and expertise in the field of MD Regulation (ideally 5+ years work experience) 

Technical competency and expertise in the field of MD Clinical evaluation

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