Regulatory Affairs Lead Specialist

Job Summary Rejoignez GE HealthCare en tant que Spécialiste principal(e) en affaires réglementaires et jouez un rôle clé dans la construction de l’avenir de l’imagerie médicale. Ce poste de leadership à dimension internationale offre l’opportunité de piloter les stratégies réglementaires et de diriger des équipes transverses afin de commercialiser des solutions innovantes d’imagerie en mammographie. Intégrez un environnement dynamique où votre expertise aura un impact direct sur la prise en charge des patients et les résultats de santé à l’échelle mondiale. Please note that this position is offered as a fixed‑term contract. Key Responsibilities Lead global regulatory projects to secure market authorization and promotional approval for medical devices. Collaborate closely with product development teams, including engineering, marketing, clinical investigations, and regional regulatory experts. Develop and implement regulatory strategies aligned with business objectives, including target markets, clinical claims, and timelines. Identify and define product testing and clinical study requirements to support regulatory submissions. Analyze and organize scientific data to demonstrate the safety and efficacy of medical devices. Prepare and submit regulatory documentation to authorities across global markets including the US, Canada, Latin America, Europe, China, and Asia. Provide regulatory guidance throughout the product development lifecycle to ensure compliance with international standards. Evaluate design changes and determine licensing or registration needs. Review and approve promotional materials to ensure alignment with regulatory claims. Monitor regulatory trends and communicate new requirements to internal teams. Support regulatory inspections and audits as needed. Qualifications Advanced experience in Regulatory Affairs, ideally within the medical device industry, or advanced experience in product development within the medical device industry. Bachelor’s degree from an accredited university or college, or equivalent relevant experience. Strong analytical, problem-solving, and project management skills. Excellent oral and written communication abilities. Proficiency in English (written and spoken). Preferred Qualifications Experience interacting with global regulatory agencies (e.g., FDA, Notified Bodies, NMPA). Knowledge of Quality Management Systems (QMS) and regulatory compliance frameworks. Proven ability to work independently in a fast‑paced, dynamic environment. Adaptability to change and capability to drive positive transformation. Strong team orientation and responsiveness to customer needs. Detail‑oriented with a focus on delivering results. Experience working in multicultural and cross‑functional teams. About GE HealthCare GE Healthcare est l'un des leaders mondiaux dans le domaine des technologies médicales et des solutions numériques. Avec plus de 100 ans d'expérience et 47 000 collaborateurs à travers le monde, l'entreprise propose des équipements intelligents, des analyses de données, des applications et des services qui permettent aux cliniciens de prendre des décisions plus rapides et pertinentes. Présente en France depuis 1987, elle compte aujourd’hui 2 800 collaborateurs, des sites industriels, un centre de R&D et des partenariats de recherche avec des entreprises et des institutions françaises. Inclusion & Diversity Statement GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. Additional Information Relocation Assistance Provided: No #J-18808-Ljbffr