Senior Manager Regulatory Affairs

il y a 5 jours


Les Ulis, France elemed Temps plein

Senior Regulatory Affairs Consultant The Company: If you are a QA/RA professional with an interest in innovation and groundbreaking development, we have an incredible role for you. This is a chance to join an established midsize Software as a Medical Device company. Role Responsibilities & Qualifications: Develop and execute regulatory strategies/plans that comply with global regulatory requirements Lead U.S. FDA submissions Lead Design control and design change activities Ensure Regulatory Affairs files are maintained to support compliance with regulatory requirements 5-7 years of experience in a regulatory affairs position for medical devices Experience in project management and submission of FDA 510(k) Experience in clinical investigation Good level of English (written/oral) Great technical skills and operational excellence ✉️ If you are interested in this exciting role, please send your application directly to ahmed@elemed.eu 📲 For more opportunities, visit https://www.elemed.eu/vacancies/ ⚖️ We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Seniority level: Mid-Senior level Employment type: Contract Job function: Quality Assurance Industries: Medical Equipment Manufacturing and Biotechnology Research Location: Boulogne-Billancourt, Île-de-France, France #J-18808-Ljbffr



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