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Regional Regulatory Affairs Lead, US
Regional Regulatory Affairs Lead, US
Neko HealthAbout the role
Neko is seeking its first Regional Regulatory Affairs Lead for North America to build the US regulatory function from the ground up. This pivotal role involves managing the relationship with the FDA, including device submissions, and holding statutory roles like US Agent and Medical Device Distributor. The ideal candidate will have 8+ years of medical device regulatory affairs experience, with a strong focus on FDA-regulated devices and a proven track record in US clearances or approvals. You will be instrumental in shaping Neko's global regulatory strategy and enabling the expansion of preventative healthcare devices in the US market.
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