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Surgitec Robotics develops Surge One, a new generation of AI-assisted surgical robotics designed for hard-tissue procedures such as neurosurgery, spine, orthopedics and ENT. Role In a demanding regulatory environment (MDR 2017/745, FDA 21 CFR Part 820, ISO 13485), the Quality Assurance Specialist acts as a catalyst for innovation: turning quality requirements into drivers of development rather than obstacles. The position holder is the key point of contact for Quality-related matters across all internal teams, fostering a culture in which quality is integrated from the design stage (Quality by Design). The QA Specialist contributes to defining and implementing Surgitec Robotics’ overall quality strategy, supporting the development, conduct of clinical trials, industrialization, and market launch of the Surge One® robotic platform. The QA Specialist ensures compliance of the Quality Management System (QMS) and serves as the primary contact for notified bodies, as well as the lead reference for the preparation, coordination, and hosting of audits and inspections. Attributions A. Owner of the Quality Management System (QMS) • Create, maintain, and continuously improve the QMS in compliance with regulations of target markets (e.g., ISO 13485, MDR, and QMSR), • Manage and update QMS procedures, work instructions, and forms, and support their implementation through the establishment of training and communication processes, • Lead internal audits and conduct supplier audits B. Strategic Partner to Development Teams • Integrate quality and regulatory requirements from the design phase (Design Controls) by supporting R&D, Hardware, Software, and Clinical Affairs teams using a risk-based approach, • Participate in FMECA workshops, risk analyses, and design reviews, positioning quality as an enabler, • Propose pragmatic solutions to regulatory challenges encountered during development, • Coordinate product risk management in accordance with ISO 14971 C. Non-Conformities, CAPA & Continuous Improvement • Manage the process for handling non-conformities and complaints (post-market), • Drive corrective and preventive actions (CAPA) with the relevant teams (post-market), • Analyze quality data and propose measurable improvement plans, • Contribute to management reviews and prepare quality indicators (KPIs) D. Supplier & Subcontractor Management • Qualify and evaluate suppliers, • Write and negotiate Quality Agreements with strategic partners, • Manage supplier non-conformities and related action plans Expected profile Education • Master’s degree (MSc or Engineering degree) in Quality, Biomedical Engineering, Life Sciences, Mechatronics, Pharmacology, or equivalent, • A specialization or certification in quality management (ISO 13485 Lead Auditor, ASQ CQE, RAPS RAC) is a strong asset Experience • 5 to 7 years of experience in a quality role within complex medical devices (hardware, software, and artificial intelligence), • Proven experience with Class IIb or III products (active medical devices, implantables, robotic surgery highly valued), • Experience in robotics is a plus, • Participation in at least one market launch (CE marking under MDR and FDA 510(k)/PMA submission) is required, • Experience in a startup or innovative SME environment: ability to build quality systems “from scratch” Knowledge • Strong command of the European Medical Device Regulation MDR 2017/745 and standards ISO 13485, ISO 14971, • Knowledge of standards IEC 62304 (medical device software), IEC 60601 (electrical safety), and ISO 10993 (biocompatibility), • Understanding of design and development processes: Design Controls, DHF, RMF, DMR, DHR, • Solid foundation in risk management, • Knowledge of FDA 21 CFR Part 820 and QSR/QMSR is a plus, • Basic understanding of cybersecurity and computer system validation (CSV/CSA) applied to medical devices, • Knowledge of regulations related to Artifcial Intelligence, • Knowledge of cybersecurity requirements Know-how • Document writing and management: procedures, protocols, technical files, • Conducting internal and supplier audits, • Implementation and monitoring of CAPA processes and non-conformity management, • Use of QMS tools, • Development and monitoring of Quality dashboards (KPIs, management reporting), • Ability to write clear regulatory summaries for non-technical audiences Interpersonnal skills • Facilitator with a solution-oriented mindset, • Start-up spirit: agility, pragmatism, ability to prioritize in a resource-constrained environment, • Cross-functional leadership: ability to influence without formal authority and rally teams around a Quality culture, • Rigor and organization without excessive bureaucracy: applying the “right-sized quality” principle, • Intellectual curiosity: active monitoring of regulatory and technological developments in the sector, • Resilience and adaptability: comfortable with uncertainty and pivots inherent to a start-up environment Language • French: bilingual, native, • English: fluent (C1) — documentation, audits, international partners, etc. Why join us ? • Make a real impact : Contribute to technologies that improve surgical precision and patient outcomes, transforming lives every day., • Work at the forefront of innovation : Be part of a pioneering team developing next-generation surgical robotics, combining engineering, AI, and healthcare expertise., • Collaborate with passionate experts : Work alongside talented professionals from diverse backgrounds, all driven by a shared mission to advance healthcare. Position based in Amiens or Montpellier Opportunity for partial remote work

Surgitec Robotics develops Surge One, a new generation of AI-assisted surgical robotics designed for hard-tissue procedures such as neurosurgery, spine, orthopedics and ENT Role The Regulatory Affairs Specialist is the regulatory architect of our robotic surgery assistance platform: they translate every requirement from certification bodies (EU and US) into practical, actionable steps. A true co-pilot of innovation, they proactively identify the most favorable regulatory pathways and turn compliance into a competitive advantage rather than a barrier to development. In a startup environment, they contribute to building the regulatory strategy, anticipate the expectations of notified bodies, and prepare the company for its first CE and FDA submissions. With a facilitative approach, they act as a trusted partner for R&D, Quality, and Leadership teams, always proposing pragmatic solutions. Attributions 1. Regulatory Strategy & Planning • Drive the overall regulatory strategy for our robotic surgery assistance platform as defined by management for the European (MDR 2017/745) and U.S. (FDA 510(k)) markets, • Select and manage relationships with the Notified Body (NB): audit preparation, document reviews, and responses to questions, • Conduct international regulatory intelligence (MDR, FDA, IEC 62304, IEC 60601, etc.) and assess impacts on the development program, • Advise Management and R&D on regulatory milestones, non-compliance risks, and opportunities for accelerated pathways, • Define the device classification and optimal regulatory pathway in collaboration with technical teams 1. Technical Documentation & Regulatory Submissions • Prepare, maintain, and submit the Technical File / Design Dossier with support from R&D and in collaboration with the QA Specialist, • Write and coordinate dossier sections: device description, clinical data, performance evaluation, risk management (ISO 14971), • Prepare FDA submissions: 510(k) pre-submissions, Q-submissions, and responses to Additional Information Requests (AIR), • Manage product registrations (EUDAMED, FDA GUDID) and CE certificate renewals 1. Regulatory Integration into Product Development • Participate in Design Reviews from the conceptual phase to anticipate applicable regulatory requirements, • Define and maintain the list of applicable standards (IEC 62304, IEC 60601-1, etc.) and ensure their integration into V&V plans, • Contribute to writing specifications and regulatory requirements within the Design History File (DHF), • Assess the regulatory impact of each product modification (change control) and determine whether a new submission is required 1. Clinical Evaluation & Post-Market Data • Contribute to drafting and updates of the Summary of Safety and Clinical Performance (SSCP), Clinical Evaluation Report (CER), and Periodic Safety Update Report (PSUR), • Lead the Post-Market Clinical Follow-up (PMCF) plan and Post-Market Surveillance (PMS) plan in compliance with MDR, • Manage vigilance obligations: reporting serious incidents, Field Safety Corrective Actions (FSCA), and FSCA communications to users 1. Labelling, IFU & Product Documentation • Review Instructions for Use (IFU), labels, and product documentation in accordance with MDR Annex I and applicable standards, • Ensure labelling compliance with the specific requirements of each target market (UDI, symbols, translations), • Manage the Unique Device Identification (UDI) system: code assignment, EUDAMED / GUDID registration, and maintenance 1. Training & Internal Regulatory Culture • Train and raise awareness among teams—particularly R&D, Quality, and Production—on applicable regulatory requirements, • Produce clear and accessible regulatory summaries for non-specialist audiences (management, investors), • Contribute to drafting internal SOPs related to regulatory affairs, • Represent the company during interactions with competent authorities (ANSM, FDA) and notified bodies Expected Profile Education • Master’s degree (MSc or Engineering degree) in Quality, Biomedical Engineering, Life Sciences, Mechatronics, Pharmacology, or equivalent, • A specialization or certification in Regulatory Affairs (RAC (RAPS), EU QP, ISO 13485 Lead Auditor) is an asset, • Knowledge of AI regulations in Europe and the United States, • Knowledge of regulations related to medical device cybersecurity in Europe and the United States, • Additional training in clinical evaluation (MEDDEV, MDR) or medical device law is a plus Experience • 5 to 7 years of experience in a Regulatory Affairs role within the complex medical device sector (hardware, software, and artificial intelligence), • Proven experience with Class IIb or III active medical devices, ideally with a software component, • Experience with active medical devices, implantables, and robotic surgery is highly valued, • Participation in at least one CE submission (MDR or MDD) and/or FDA 510(k) / PMA submission is mandatory, • Experience managing relationships with a Notified Body is valued, • Experience in a startup or innovative SME environment: ability to build a regulatory function “from scratch” Knowledge • Strong proficiency of EU Regulation 2017/745 (MDR): General Safety and Performance Requirements (GSPR), Annexes I to XVII, • Knowledge of key harmonized standards: IEC 62304, IEC 60601, ISO 14971, ISO 13485, ISO 15223, ISO 10993, • Mastery of FDA requirements: 21 CFR Part 820, CDRH guidance documents, and 510(k) / De Novo / PMA pathways, • Knowledge of the clinical evaluation framework (MEDDEV 2.7/1 rev.4, MDCG 2020-5/6/13) and clinical investigations (ISO 14155), • Proficiency in UDI requirements (MDR Annex VI) and the EUDAMED system, • Knowledge of cybersecurity requirements applicable to medical devices (FDA guidance, MDCG 2019-16) Know-how • Drafting Technical Files and Design Dossiers compliant with MDR Annex II, • Structuring and writing 510(k) submissions, Pre-Submissions (Q-Sub), and responses to FDA questions, • Leading and contributing to Clinical Evaluation Reports (CER) and systematic literature reviews, • Ability to produce clear regulatory summaries for non-technical audiences, • Conducting or coordinating MDR gap analyses and associated remediation plans, • Managing regulatory registrations: EUDAMED, FDA 510(k) databases, PMA modules, • Assessing the regulatory impact of product modifications (change control analysis) Interpersonal skills • Development facilitator: turning regulatory requirements into opportunities for product robustness and accelerated time-to-market, • Strong communication and teaching skills: making complex requirements understandable for engineers, surgeons, and investors, • Startup mindset and pragmatism: prioritizing, simplifying, and building risk-proportionate processes (right-sized compliance), • Curiosity: actively monitoring regulatory developments, • Resilience and adaptability: navigating regulatory uncertainty typical of innovative devices and startup environments Language • French: bilingual, native, • English: fluent (C1) — documentation, audits, international partners, etc. Why join us ? • Make a real impact : Contribute to technologies that improve surgical precision and patient outcomes, transforming lives every day., • Work at the forefront of innovation : Be part of a pioneering team developing next-generation surgical robotics, combining engineering, AI, and healthcare expertise., • Collaborate with passionate experts : Work alongside talented professionals from diverse backgrounds, all driven by a shared mission to advance healthcare. Position based in Amiens or Montpellier Opportunity for partial remote work

We are seeking a highly motivated Postdoctoral Researcher to join the GRAMFC (Inserm UMR1105) laboratory at Picardie Jules Verne University, Amiens, France. Role Summary This position sits at the intersection of neuroscience and artificial intelligence. You will join a multidisciplinary team to advance our understanding of preterm brain development. By leveraging one of the world’s largest neonatal EEG datasets—comprising over 15,000 recordings from Amiens University Hospital—you will develop innovative models of cerebral maturation. This role is pivotal in our mission to create interpretable, scalable clinical tools that enhance the evaluation of brain development in preterm neonates. What Success Looks Like Success in this role will be defined by your ability to bridge complex EEG signal processing with high-performance machine learning. You will be successful if you can: • Develop robust, interpretable AI-based models that accurately map developmental trajectories during the second and third trimesters., • Translate large-scale EEG data into actionable insights for clinical applications., • Collaborate effectively across our research units (GRAMFC/MIS) to produce high-quality scientific output. Responsibilities • Conduct large-scale analysis and phenotypic characterization of neonatal EEG data., • Design and implement machine learning and AI models to identify patterns of cerebral maturation., • Develop scalable, user-friendly tools suitable for clinical evaluation and decision-making., • Document methodologies and research findings to contribute to international publications and academic discourse., • Work under the co-supervision of Prof. Sahar Moghimi and Prof. Florence Levé to align project goals with the laboratory's strategic research objectives. Qualifications • Education: PhD in Neuroscience, Biomedical Engineering, Data Science, or a closely related field., • Technical Skills: Advanced proficiency in Python and extensive experience in machine learning/AI modeling., • Domain Expertise: Strong, demonstrated experience in EEG analysis and/or time-series analysis., • Analytical Ability: Proven capacity to manage and derive insights from large, complex datasets (highly desirable)., • Soft Skills: Strong interest in neurodevelopment and the ability to work effectively in a collaborative academic environment. Position Details • Location: Amiens, France, • Duration: 12 months, • Start Date: September 2026, • Salary: Based on University standards (commensurate with experience) How to Apply Please submit your CV (including an up-to-date publication list), a motivation letter, and the contact information for two referees to sahar.moghimi@u-picardie.fr and florence.leve@u-picardie.fr. Submission Deadline: June 15th, 2026 #Postdoc #ResearchOpportunity #AI #Neuroscience #MachineLearning #EEG #NeonatalDevelopment #Hiring #AcademicJobs #DataScience

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Participer au développement d'une culture Data au sein de l'entreprisePROFILRigueur, curiosité et esprit analytiqueCapacité de synthèse et aisance rédactionnelleAppétence pour la manipulation des données chiffréesEsprit d'équipe et bonnes compétences en communicationMaîtrise a