Regulatory Coordinator (Remote)

Hyfe Inc. (www.hyfe.com) is the global leader in continuous cough monitoring. Our software runs on ubiquitous personal electronic devices and enables passive, long-term monitoring of cough frequency, revealing novel health insights.

Hyfe delivers cough monitoring and treatment solutions 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.

Overview:

For a first-of-its-kind digital therapeutic (DTx), powered by continuous cough detection, and currently in its Phase 3/pivotal clinical trial, Hyfe is seeking a highly motivated Regulatory & Quality Documentation Specialist to author and develop design documentation for a Software as a Medical Device (SaMD) product for the Japanese market. Reporting to the Quality Manager, you will support preparation of the Shonin (marketing approval) application, including STED documentation for our Japanese client, and support PMDA QMS conformity inspections. Your role will also include the management and continuous improvement of Hyfe’s QMS and actively supporting internal and external audits.

Key Responsibilities:

STED Documentation

• Prepare the STED sections requested by the client, drawing on design documents, verification and validation reports, and risk management records.
• Structure content to meet Japanese medical device requirements, including software lifecycle, risk management, and cybersecurity.
• Draft responses and supporting evidence for PMDA inquiries.

QMS Management

• Support QMS compliance with appropriate internal and external regulatory requirements.
• Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
• Engage in the development of the QMS for continuous improvement and business needs.
• Prepare responses and additional evidence for document-based and/ or on-site inspections.
• Keep QMS and design documentation up to date for periodic inspections.

Other Shonin submission-related tasks

• Prepare documents for Foreign Manufacturer Registration in Japan.

Required Qualifications:

• English: Advanced. Able to write regulatory-grade technical documents and comfortable collaborating with multicultural team members worldwide.
• Regulatory experience: 2+ years in medical device or SaMD regulatory affairs (strong preference for PMDA or FDA). Experience of drafting technical documentation for regulatory submissions (e.g., FDA, PMDA, etc.)
• Location: EU, North America or Japan. Fully remote.
• Remote work: Proven ability to work independently in a fully remote role: plans own work, meets deadlines without close supervision and raises issues early.
• Working hours: ET (with periodic out-of-hours calls with Japan and Europe)



Preferred Qualifications:

• Native or fluent Japanese is a strong asset
• Knowledge of IEC 62304, ISO 14971, IEC 62366-1 and IEC 81001-5-1
• SaMD approval experience in Japan
• Experience in the Japan operations of an overseas medical device manufacturer

Duration: 6 months, with potential for extension

To Apply Please Complete This Questionnaire:

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