Mar 17, 2026
CSL
The Lead, Global Regulatory Affairs Device is responsible for: Developing, coordinating and implementing global Software as a Medical Device regulatory strategies for new combination and standalone medical devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with regulatory agencies. This role promotes strong cross-functional collaboration and effective communication across Global Operations, Plasma Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to...
Professional Diversity Network
King of Prussia, PA, USA
Full-Time
