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
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
Ces entreprises recrutent aussi au poste de “Conseil en conformité réglementaire”.