AI-powered cough-tracking & insights. Precision medicine for respiratory health
Wilmington, Delaware
Hyfe is the global leader in AI-powered cough-monitoring technology. Our patented machine-learning software enables passive, long-term monitoring of cough frequency, revealing novel health insights. We deliver cough-monitoring solutions that empower pharma and academic researchers to advance clinical trials, enable healthcare providers to optimize patient care, and power digital therapeutics to transform the management of respiratory illness, including chronic cough. Our technology has been used in 50+ clinical studies, and our long-term partners include global pharma companies and leading academic institutions.
Remote · Japan
Prepare STED and other regulatory submission documentation for a SaMD product seeking Japanese marketing approval, including supporting evidence and responses to PMDA inquiries. Maintain and improve the QMS, keep design and quality documentation current, and support audits, inspections, and Foreign Manufacturer Registration in Japan.
Remote · Canada, Japan
Prepare STED and other regulatory submission documentation for a SaMD product seeking Japanese marketing approval, including supporting evidence and responses to PMDA inquiries. Maintain and improve the QMS, keep design and quality documentation inspection-ready, and support audits and PMDA inspections.
