Drugs, Devices & Combination Products
As Senior Director, Marielle has several responsibilities within the management of projects involving the design and implementation of global regulatory strategies for the development, evaluation and marketing of medical devices & medicinal products, as well as combination products (i.e. drug/device, including combined ATMPs) and borderline products. She actively participates to the redaction and review of ATMPs and Combined ATMPs US/EU dossiers. She closely follows the evolution of new regulations.
Marielle also specializes in Quality regulations, such as ISO 9001 / ISO 13485 and EU GMP regulations, and has good knowledge on QSR (21 CFR part 820). She assists in the identification, development and implementation of Quality Systems appropriate to the need, complexity and size of an organization.
Marielle has also important knowledge in European medical devices vigilance (including FSCA and FSN), as well as pharmacovigilance management.
Prior to joining VCLS, Marielle was Regulatory Affairs Director and Responsible Pharmacist (QP) for the La Rochelle site of Carl Zeiss Meditec - Surgical Ophthalmic Business Unit, manufacturing and marketing ophthalmic devices, including implantable and sterile medical devices worldwide as well as ophthalmic medicinal products registered through Mutual Recognition Procedure in Europe. She headed the regulatory affairs team in charge of registration and Life Cycle Management. She also supervised the Quality Assurance department of this company for several years.
Marielle previously worked for Columbia Laboratories, an American development company as Regulatory Affairs Officer for hormonal medicinal products and was fully involved in development, sub-contract manufacture and controls of products, as well as 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).