As a Senior Director at VCLS, Marielle is responsible for leading the Medical Device and Combination Products Group, as well as the VCLS Microbiome Task Force.
Marielle follows closely the evolution of new regulations and she has specific expertise in the design and implementation of global regulatory strategies to support the development, evaluation and marketing of medical devices and medicinal products, as well as combination products (device/drug and drug/device combinations, including combined ATMPs) and borderline products. She is also responsible for managing projects concerned with the regulatory development and product-positioning of innovative health products, together with the formulation of regulatory strategy and the development of regulatory roadmaps for microbiome-related health products. In addition, she actively participates in, or supervises, the redaction and review of US/EU dossiers for ATMPs and Combined ATMPs.
Marielle also specializes in developing strategies to comply with the requirements specified in the “Quality Regulations”, such as ISO 9001 / ISO 13485 and EU GMP regulations, and the US QSR (21 CFR part 820). She is therefore ideally placed to be able to help clients in the identification, development and implementation of Quality Systems appropriate to their needs, complexity and size.
She brings to the role substantial experience in the fields of ophthalmic, implantable and sterile devices and drugs.
Prior to joining VCLS, Marielle was employed by Carl Zeiss Meditec as a Regulatory Affairs Director and Responsible Pharmacist (QP). Whilst there, she headed the regulatory affairs team in charge of registration and life cycle management and was responsible for supervising the Quality Assurance department for several years. Marielle started her career working for Columbia Laboratories as a Regulatory Affairs Officer, where she had responsibility for the development, sub-contract manufacture and control of products, as well as product registration and life-cycle management.
Marielle earned her Pharm.D. degree from the Universities of Pharmacy of Paris XI (Chatenay Malabry) and Clermont Ferrand, France, followed by a post-graduate diploma in Health Care Laws at the Law University of Paris XI (Sceaux). She is based at the VCLS office in Rennes, France.