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Global Regulatory Affairs Lead for AI Med Devices

Sonio, WorkFromHome

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A pioneering medical technology company based in Boston is hiring a Regulatory Affairs Specialist to lead the regulatory strategy for AI/ML-enabled devices. The ideal candidate will manage FDA submissions and ensure compliance with medical device regulations. A Bachelor's degree and over 6 years of experience in regulatory affairs are essential, along with excellent communication skills in English and Korean. This role offers a competitive salary of $160,000 plus a bonus and hybrid working conditions.
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