Audrey is a Regulatory Affairs professional with background in worldwide regulatory submissions for various medical devices and growing experience in medicines. She is a key member of the regulatory team supporting clients on a wide range of Regulatory Affairs projects.
Value to clients
Audrey brings a wide range of skills and experience to effectively manage multiple projects, ensuring compliance to the applicable legislation.
- Knowledgeable and experienced in every aspect of medical devices Regulatory Affairs, from product development and creation of technical files to CE marking and lifecycle management
- Proactive, adaptable and well organised to ensure that project deadlines and objectives are met
- Extensive experience in literature searches and clinical evaluation writing
- Experienced in CTAs, MAAs and life-cycle maintenance for medicines
- Diligent and analytical with a healthy attention to detail.
After pharmaceutical studies which culminated in a Masters in Engineering of Medical Devices, Audrey worked in the Regulatory Affairs departments of small and medium-sized medical devices companies in France. She acquired experience in the management of a large catalogue of sterile single-use and active medical devices from the early stage of their design to the end of their life. This gave Audrey great experience of ensuring that the products were compliant with the regulations whilst taking into account the constraints imposed by a small company size. Since joining Regulis, Audrey has extended her regulatory knowledge into medicinal products while increasing her experience on the new Medical Devices Regulation and its implementation.
Other things about Audrey
- French native speaker
- Knowledgeable in in vitro diagnostic medical devices
- Experienced in building robust Quality Management Systems.