Regulatory Coordinator (Remote)

Job summary

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.

Job details

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: https://forms.gle/AMWZdG6S86EpUjLRA (no direct inquiries will receive replies)

What you’ll do

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.

Requirements

Applicants need at least two years of medical device or SaMD regulatory affairs experience and experience drafting technical documentation for regulatory submissions; PMDA or FDA experience is strongly preferred. Advanced English and the ability to work independently in a fully remote role are required, while Japanese fluency and familiarity with relevant IEC and ISO standards are preferred.

Listed skills

• Risk Management · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory Affairs
• Medical Device Regulatory Submissions
• STED Documentation
• Software as a Medical Device
• Quality Management Systems
• PMDA Submissions
• FDA Submissions
• Risk Management
• Software Lifecycle Documentation
• Cybersecurity Documentation
• Verification and Validation
• Audit Support
• Regulatory Inspection Support
• Technical Writing
• QMS Continuous Improvement

Job areas

• Healthcare
• Legal
• Technology
• Administrative

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