Requirements: English
Company: Ortho Clinical Diagnostics
Region: Milan , Lombardy
QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with expertise in immunoassay, molecular testing, clinical chemistry, and transfusion medicine. We are more than 6,000 employees strong, operating in over 130 countries, providing fast, accurate, and reliable testing where it is needed mosthome, hospital, lab, and clinic.Our culture prioritizes our team members'' happiness, inspiration, and engagement. We believe that employee well-being and business success go hand in hand. Join us in our mission to harness diagnostics to build a healthier future for all.Your new roleYou will ensure compliance of regulatory processes and strategies with local and international regulations, as well as QuidelOrtho standards. Your responsibilities include developing and implementing regulatory strategies, managing communications with regulatory agencies, customers, and the Strasbourg Center of Excellence during vigilance activities, product notifications, customer complaints, and communications. You will oversee the rollout of field safety corrective actions and field actions in collaboration with global Quality, Regulatory & Compliance teams, as well as product representatives and manufacturers. Additionally, you will manage the Quality Management System in line with the EMEA Quality strategy, support management reviews, corrective and preventive actions, and quality improvement projects.You will support commercial processes by reviewing and approving promotional materials, supporting product lifecycle management, and providing quality and regulatory input to tenders and customer contracts. You will also support internal, external, and supplier audit programs, as well as local Healthcare Compliance and EHS activities. Furthermore, you will be responsible for product registration and notifications in the Italian Ministry of Health repository, ensuring proper control and uploads.What you''ll be doingSupporting commercial activities through product lifecycle management, tender submissions, and customer contracts, including copy-review and approval of promotional materials.Managing the rollout of field actions and global customer communications, including document translation and vigilance case follow-up.Monitoring regulatory requirements for compliance, performing post-market surveillance, and managing product notifications for new and modified products.Acting as a liaison with local health authorities and representing QuidelOrtho in local regulatory associations. Delegating authority for regulatory file uploads in the Italian MoH repository.Managing and improving the Quality Management System, conducting management reviews, maintaining documentation, supporting training and quality improvement projects, and supporting audit processes.Supporting customer complaint systems and responding to quality requests in collaboration with the hotline.Compliance: Supporting EMEA Healthcare Compliance, Privacy, and Transparency reporting, as well as local environmental and safety legislation compliance (e.g., REACH, RoHS, WEEE).What you''ll need to succeedTechnical degree or diploma in chemistry, biochemistry, biology, pharmacy, engineering, or related field.3-5 years of experience in a regulated industry (Medical Devices, IVD, or pharmaceuticals).Ability to work independently.Strong knowledge of Italian regulations and local compliance, with experience interacting with authorities like the Ministero della Salute.Good understanding of the IVD Medical Device regulatory environment.Experience managing Quality Systems according to ISO 9001 and ISO 13485 standards.Fluent in English and Italian (oral and written).#J-18808-Ljbffr