Remote SaMD Regulatory
2 days ago
Canada
Hyfe
Full-time
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Hyfe Inc. is seeking a Regulatory & Quality Documentation Specialist to author design documentation for a SaMD product aimed at the Japanese market.
You will support STED documentation, PMDA responses, and QMS improvements while coordinating with a global, remote team. Requirements include advanced English, 2+ years in medical device or SaMD regulatory affairs, and the ability to work independently across time zones (ET to Japan/Europe).