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 in the EU and US, including CTAs, INDs, NDAs, MAAs and variations.
- Knowledgeable and experienced in every aspect of medical devices Regulatory Affairs, from product development and creation of technical files to worldwide registration and lifecycle management
- Proactive, adaptable and well organised to ensure that project deadlines and objectives are met
- Skilled in post-approval vigilance
- 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.
Other things about Audrey
- French native speaker
- Worldwide medical devices experience
- A keen interest in Quality Assurance.