Senior Regulatory Lead, Medical Devices

IQVIA is seeking a Principal Medical Writer to lead the development of regulatory documents for submissions to regulatory authorities worldwide. You will provide strategic direction to cross-functional project teams and serve as lead writer for key summary documents, ensuring high-quality, data-driven messaging.The role requires a Bachelor's degree (advanced...

TheraPanacea, a medical technology company focused on AI to improve cancer care, is seeking a Regulatory & Quality professional in France. The role ensures compliance with MDR and global standards, maintains the quality and information security management systems, and supports the development of controlled documents and training materials.The ideal candidate...

Robeaute seeks a Software Test Engineer to lead verification and validation of clinical software across embedded, backend, and frontend systems. You will ensure safety, performance, and regulatory compliance, while coordinating with cross-functional teams and QA/RA.The role focuses on test strategy, environments, and design controls, with strong emphasis on...

Insulet Corporation seeks an experienced Medical Device Vigilance Specialist with deep expertise in French vigilance requirements and direct experience working with French Competent Authorities. The role focuses on ensuring compliance with post-market surveillance and vigilance obligations in France, serving as the country-specific expert.You will lead...

BIO15PHARMA recherche un Responsable Affaires Réglementaires & Senior Medical Writer pour piloter la stratégie réglementaire internationale et la production documentaire à forte valeur réglementaire. Vous coordonnerez les soumissions et assurerez la conformité des dossiers tout en assurant une veille réglementaire continue.Intégré au sein de...

Theodo HealthTech à Paris recherche un Senior Software Engineer pour concevoir et développer des applications web et mobiles certifiées dispositifs médicaux. Vous ferez partie d’une équipe à taille humaine (4 à 5 personnes) et collaborerez étroitement avec le client, le tech lead et le product manager.Vous utiliserez des assistants de coding...

Galderma is seeking a Senior Clinical Quality Assurance Manager to join the R&D Quality Assurance team in Barcelona. You will contribute to ensuring quality and regulatory compliance of clinical development activities, working with clinical study teams and external partners to provide GCP expertise and oversee quality risks.You will coordinate audits,...

En Carta Diagnostics in Paris is seeking a Senior Regulatory & Clinical Affairs Manager to own regulatory and clinical strategy for IVDR and FDA pathways, guiding products from technical file to market authorization.You will lead cross‑functional teams across biology, engineering and quality, build robust regulatory routes, and ensure timely, compliant...

Ipsen is seeking an experienced CMC Regulatory Director to lead the regulatory strategy for assigned projects from development through lifecycle management. You will coordinate with Global Regulatory Affairs, Manufacturing, and external partners to ensure compliant CMC submissions and timely interactions with authorities.Ideal candidates will have 8–10...