Senior Device Quality Engineer & Compliance Expert

<p>Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail. </p><p>This job offer is accessible to all, regardless of gender. </p><p></p><p><b>Job title:</b> Senior Device Quality Engineer &amp; Compliance Expert</p><p></p><h1>About the job</h1><p></p><p><b>Our Team:</b></p><p></p><p>The Global Device and packaging Quality (GDPQ) group’s mission is to safeguard the quality of our products by promoting the application of best practices for the development, industrialization, and manufacturing of medical devices, in accordance with applicable regulations and Sanofi Quality Systems. This mission is carried out in collaboration with the Global Device and Packaging Unit for Device Development and Device Life-cycle Management, Operations, and Quality teams of Sanofi Specialty Care, General Medicines, and Vaccines in the execution of common goals.</p><p></p><p>The group provides GQ operational support for medical devices and Drug-Device combination product quality spanning development, industrialization, manufacturing, and post-market changes. The group also provides quality leadership to ensure product/process robustness, successful outcomes for regulatory <span>submissions/inspections,</span> and launch readiness activities.</p><p> </p><p><b>Main responsibilities:</b></p><ul><li>Quality representative on cross-functional development teams to support regulatory compliance and best practice integration for design development projects</li><li>Utilize deep expertise to inform development and lifecycle activities regarding device regulatory framework, CE marking process, notified body interactions, audits, certifications and CE marking, legal manufacturer requirements, and submission skills. Refer to the technical skills section</li><li>Ensure quality-related aspects are sufficiently detailed throughout the entire product development life cycle from early development, including product maintenance aspects for new device introductions</li><li>Participate in design reviews and provide expertise to ensure potential problems are identified and corrected early in development to minimize impact to broader project <span>scope/resources/budget</span></li><li>Provide expert assessment for proposed design and/or process changes, and post-launch changes to design intent and state of the art status, support change control and implementation activities as needed</li><li>Support regulatory submissions pre and post-launch, and liaise with global regulatory as well as alliance partners for review of submission documentation and IR’s</li><li>Mentor, train, and support the development of engineers within the department and cross functionally</li></ul><p></p><h1>About you</h1><p></p><p><b>Experience</b><b>:</b></p><ul><li>Minimum 15 years in functions related to Quality, Regulatory, or Development of Medical Devices and Drug-Device Combination products</li></ul><p></p><p><b>Soft skills</b><b>:</b></p><ul><li>Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results</li><li>Leading and influencing without authority in a highly matrixed organization</li><li>Ability to assess and communicate complex compliance and technical issues, developing and delivering engaging presentations suitable for audiences at all levels of the organization</li><li>Ability to coach and mentor others in the device development and compliance</li></ul><p></p><p><b>Technical skills</b><b>:</b></p><ul><li><b>N</b><b>otified Body Interaction - </b>Preparing for and managing Notified Body audits and reviews, Notified Body designation and scope, Addressing Notified Body feedback, nonconformities, and corrective actions, Navigating EUDAMED registration and requirements</li><li><b>Documentation and Submission Skills </b>- Knowledge in writing and compiling Technical Files/Design Dossiers, UDI strategy, Declaration of Conformity (DoC) process, Generating Summary of Safety and Clinical Performance for Class III/implantable devices</li><li><b>Cross-Functional Communication &amp; Project Management</b> - Coordinating with R&amp;D, Clinical, QA/RA, Manuf, and Marketing regulatory strategy and timelines. Interpreting and communicating regulatory impact of product changes</li><li><b>Global Regulatory Insight </b>-Knowledge of international regulatory pathways (e.g., US FDA, Health Canada, TGA, PMDA). Harmonization with IMDRF guidelines</li></ul><p></p><p><b>Other:</b></p><ul><li>Strong analytical skills, and ability to understand complex problems and structure into logical workstreams for resolution</li><li>Ability to communicate technical content in an efficient manner, verbally and with technical writing skills</li><li>Ability to develop presentations and communicate effectively that is scaled appropriately for the audience</li><li>Ability to work with ambiguity, make decisions, and influence others withou