Global Medical Device Regulatory Specialist

Hace 2 días

España Kelly Jornada completa

Kelly is seeking an experienced Regulatory Affairs Specialist to drive global market access for its medical device portfolio. You will compile technical documentation and manage submissions under EU MDR and FDA requirements, while collaborating with R&D, Quality, and Clinical teams to ensure regulatory compliance.

You will coordinate with Notified Bodies and authorities, assess changes for regulatory impact, and review labeling, IFUs, and packaging.

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