Chloé TREMAUDANT serves as a Regulatory Affairs Specialist for In Vitro Diagnostic (IVD) devices at HORIBA Medical FRANCE (HORIBA ABX SAS), where she leverages her extensive background in chemical engineering and her Master's degree in Chemistry to navigate the complex landscape of medical device regulations....
Chloé TREMAUDANT serves as a Regulatory Affairs Specialist for In Vitro Diagnostic (IVD) devices at HORIBA Medical FRANCE (HORIBA ABX SAS), where she leverages her extensive background in chemical engineering and her Master's degree in Chemistry to navigate the complex landscape of medical device regulations. With a deep understanding of the European Directive 98/79/EC and the more recent Regulations (EU) 2017/745 and 2017/746, Chloé is instrumental in ensuring that the company’s IVD products meet stringent regulatory standards. Her role encompasses the creation and management of comprehensive technical files essential for CE marking, as well as facilitating ANSM declarations and registrations in Canada under SOR/98-282.
Chloé's expertise extends beyond regulatory compliance; she actively supports various departments within the organization, providing guidance to distributors and subsidiaries to ensure alignment with regulatory requirements. Her proficiency in Good Manufacturing Practices (GMP), ISO 13485, and quality control processes is vital in managing and monitoring compliance projects, thereby enhancing the overall quality and safety of medical devices. Additionally, her background in toxicology, cosmetics, and pharmaceuticals enriches her approach to regulatory affairs, allowing her to address challenges with a multifaceted perspective.
Chloé is not only a regulatory expert but also a strategic partner in research and development, where her insights into chemistry, biochemistry, and microbiology contribute to innovative solutions in product formulation. Her ability to communicate effectively in both French and English, coupled with her skills in data analysis using Microsoft Excel, positions her as a key player in the regulatory landscape, ensuring that HORIBA Medical remains at the forefront of compliance and innovation in the medical device industry.
