SQI

1 Job

112 Employees

About the Company

For a safer and more effective healthcare, come develop tomorrow’s technological solutions with us. Software development of medical technologies: From proof of concept to certified product, we design, develop and test your medical devices software, in compliance with IEC 62304. Surgical planning | Guidance of surgical gestures | Medical robotics | Healthcare data & business wokflow management Tailor-made support for quality and regulatory affairs, from research to market: Certify your medical innovation in the best optimized and most secure way. Regulatory strategy | Clinical investigation | CE/FDA certification

Listed Jobs

Company Name: SQI
Job Title: Consultant(e) expérimenté(e) en Qualité et Affaires Réglementaires Dispositifs Médicaux
Job Description: **Job Title** Experienced Consultant – Quality & Regulatory Affairs – Medical Devices **Role Summary** Provide end‑to‑end regulatory strategy, quality system implementation, and technical documentation for medical device clients, ensuring compliance with EU MDR/IVDR and other applicable regulations. Serve as a consultant and mentor, guiding projects from concept to market launch and clinical investigation. **Expectations** - Act as a regulatory and quality pillar for clients’ product development and deployment. - Translate complex regulatory requirements into actionable plans tailored to each stakeholder. - Maintain up‑to‑date knowledge of evolving medical‑device regulations and standards. - Mentor junior consultants and contribute to the continuous improvement of internal methodologies. **Key Responsibilities** - Develop regulatory strategy and provide actionable guidance for market access, clinical investigation, and certification. - Ensure alignment of design and development activities with regulatory and normative expectations, including CE marking. - Deploy and optimize ISO 13485 Management Systems customized for client organizations. - Prepare technical dossiers for Europe (and potentially the US), incorporating risk‑management (ISO 14971). - Manage complete submission workflows: clinical investigations, certifications, and related communications with authorities. - Lead or co‑lead projects on client sites, managing schedules, priorities, and reporting. - Conduct internal monitoring, audits, and quality‑system reviews; contribute to method and tool development. - Perform regulatory surveillance on relevant categories (electromedical, implantable, medical‑device software, AI, cybersecurity). **Required Skills** - Deep mastery of EU MDR 2017/745 and/or IVDR 2017/746. - Proficiency in technical documentation and risk‑management (ISO 14971). - Strong project‑management ability (planning, prioritisation, reporting). - Excellent written and verbal communication with diverse stakeholders (physicians, industry, project teams). - Curiosity, dynamism, and adaptability to regulatory evolution. **Required Education & Certifications** - Engineer, Master’s degree, or equivalent advanced scientific qualification in Regulatory Affairs or Health Sciences. - Minimum 5 years of experience at a medical‑device manufacturer. - (Optional but advantageous: experience with DMDIV, electromedical devices, active implants, medical‑device software, AI/Cyber‑security, and clinical evaluation.)