eMyosound

www.emyosound.com

1 Job

20 Employees

About the Company

eMyosound is an innovative med-tech company dedicated to advancing cardiac healthcare through the development of non-invasive ultrasound elastography

Listed Jobs

Company Name: eMyosound
Job Title: Stagiaire QARA
Job Description: **Job title** Intern, Quality Assurance & Regulatory Affairs (QARA) **Role Summary** Assist the Regulatory Director in establishing and maintaining the medical device company’s quality and regulatory framework. Focus on ISO 13485-compliant QMS implementation, FDA 510(k) submission preparation, cybersecurity compliance (ISO 27001), and continuous regulatory surveillance to support market access. **Expectations** - Complete all assigned tasks within a 6‑month internship period - Deliver accurate, English‑written documentation and reports - Demonstrate scientific rigor, clear writing, and proactive learning about medical‑AI technologies **Key Responsibilities** 1. **Quality & Compliance (ISO 13485 & QMSR)** - Implement and refine the QMS in line with ISO 13485:2016 and FDA QMSR requirements - Draft, edit, and parametrize procedures, instructions, and templates in the Matrix Requirements document management system - Verify completeness of DHR/D*R records to ensure audit readiness 2. **Cybersecurity & Data Protection (ISO 27001)** - Support establishment of the ISMS for software and AI components - Participate in data‑security risk assessments 3. **Regulatory Affairs & International Strategy** - Contribute to FDA 510(k) submission dossier (clinical data, performance evidence, biocompatibility) - Monitor and report on evolving EU MDR/IVDR guidance, MDCG updates, and FDA rule changes - Prepare and attend internal and certification audit activities **Required Skills** - Solid theoretical knowledge of ISO 13485; familiarity with ISO 14971 (risk management) and IEC 62304 (software lifecycle) preferred - Technical English: writing and interpreting regulatory documents in English - Proficient with digital tools for document control (e.g., Matrix Requirements) - Strong analytical and synthesis abilities; meticulous attention to detail - Curiosity and adaptability to emerging medical‑AI technologies **Required Education & Certifications** - Current enrolment in final year of an engineering program with a biomedical engineering focus, or a Master’s (MSc/M2) in Biomedical Engineering or equivalent field - No mandatory certifications, but knowledge of ISO 13485/27001/14971/62304 is essential.

Paris, France

Hybrid

06-01-2026