About this role
Regulatory Affairs Project Manager F/M/X at Nemera. Location: Lyon, Auvergne-Rhône-Alpes, France. Role: leading projects, ensuring compliance, preparing submissions Requirements: Engineering degree, 5+ years' experience in combination products or medical devices, experience leading regulatory & compliance projects, knowledge of eCTD Module 3 CMC, CE/Notified Body process, QMS/GMP, 21 CFR 820, ISO 13485, MDR 2017/745, ISO 14971; fluent English. Category: Project and Program Management Seniority: Senior Level Tools: eCTD (Electronic Common Technical Document) Commitment: Full Time Workplace: Hybrid Languages: English