Dominique Fillere
France, Lyon
Global QMR Medical Office, Clinical and Regulatory Affairs at bioMérieux
Profession: Scientist
Industry: Medical Devices, Life Sciences, Healthcare
About:
I am a Neuroscientist by education, specialized in Clinical, Regulatory and Quality for Medical Devices, as well in Strategic Information Management. Working successively in R&D, Global Marketing, Medical Affairs, Clinical and Regulatory Affairs, I had the opportunity to evolve in multicultural environments, collaborating with international business functions and supporting the global strategy to ensure quality and regulatory compliance of health products.
languages
English, French
Expertise:
Experience:
bioMérieux
Global QMR Medical Office, Clinical and Regulatory Affairs at bioMérieux
September 2021 - Present • Lyon, France
*Defining and executing the Quality System strategy for the Medical Office, as well as Clinical Affairs and Regulatory Affairs *Integrating and developing processes that meet Business needs across the Global Medical Office Organization (Medical Affairs, Companion Diagnostics and Public & Government Affairs). * Leading the consolidation and scheduling of the Medical Office and CARA Management Reviews * Performing GCP assessment and creating any action plan aligned with Global Medical Affairs and Global Clinical Affairs Management * Acting as the Quality Representative and Approver for SOP development and implementation * Supporting Inspection Readiness and Audits for the Medical Office and Global CA and RA business processes