Global Medical Device Regulatory Specialist

Kelly is seeking an experienced Regulatory Affairs Specialist to drive global market access for its medical device portfolio.

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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. xqbhyrx

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