Christelle Baille

Christelle Baille has a diverse work experience spanning multiple companies and roles. Christelle currently serves as the Head of QARA at AZmed since 2022. Prior to that, they worked at Cardiologs from 2019 to 2022, initially as a Quality Assurance & Regulatory Affairs Specialist and later as the Quality Assurance & Regulatory Affairs Manager. Their responsibilities included developing and maintaining the QMS and product documentation, implementing MDR and MDSAP in the QMS for certification, managing change control processes, leading internal and BSI audits, providing regulatory support to sales and marketing, managing post-market activities, handling NC/CAPA, complaints, and vigilance management, managing CE Marking processes, and overseeing relationships with notified bodies and regulatory agencies. Christelle also conducted regulatory and quality awareness trainings and participated in product and QMS process risk activities.

Before Cardiologs, Christelle worked at Balt Group as a Regulatory Affairs Officer from 2017 to 2019. In this role, they managed the CE marking of Class III and IIa medical devices, including monitoring product developments, elaborating technical files, developing risk management files, and renewing CE certificates.

Christelle started their career at LABORATOIRE POLIDIS as an apprentice and trainee from 2016 to 2017. As an apprentice in the Master 2 Medical Devices program, they assisted with quality assurance and regulatory affairs tasks, including the treatment and monitoring of complaints, non-conformities, and alertness. As a trainee in Insurance Regulatory and Quality Affairs, they handled claims, non-conformities, vigilance, and contributed to the drafting and updating of quality assurance procedures and dossier creation.

Christelle began their professional journey as a Saleswoman at Jennyfer from an unspecified date until 2016.

Overall, Christelle Baille's work experience demonstrates their expertise in quality assurance, regulatory affairs, and strong skills in managing QMS processes, conducting audits, and ensuring compliance with regulatory requirements.

Christelle Baille completed their education in a chronological order. Christelle began their education in 2011 at Pierre and Marie Curie University, where they pursued a degree in Biology and Chemistry. From 2015 to 2016, they attended Paris-Sud University (Paris XI) and obtained a Master 1 in Drug Sciences. Continuing their studies at the same university, they completed a Master 2 Alternation in Medical devices: Feedback, Registration, Vigilance from 2016 to 2017.