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).
📌 Remote SaMD Regulatory (Toronto)
🏢 Hyfe
📍 Toronto
Reply to this offer
Impress this employer describing Your skills and abilities, fill out the form below and leave Your personal touch in the presentation letter.