Job ScopeThe role oversees technical initiatives related to products already on the market and products undergoing registration in multiple countries. It ensures effective handling of testing and technical requests from Regulatory Authorities during registration, change, or renewal processes. Responsibilities include planning and executing IVD validation activities in alignment with company strategies, conducting scientific literature reviews, preparing technical documentation in compliance with applicable requirements, and providing in-depth technical expertise to guide Product Development contributions to post-launch strategies. The role manages a dedicated small team focused on these activities, within the Product Development Immuno.Key Duties and Responsibilities
Ensures effective management of technical requests during submission processes and regulatory transitions.Oversees technical initiatives related to launched products, products under registration in multiple countries, and products subject to changes.Verifies compliance with critical requirements in accordance with internal procedures (GOPs/SOPs) and applicable internal and external quality standards.Maintains up-to-date expertise on state-of-the-art technical requirements and evolving regulatory expectations for IVDs across different regions.Plans and executes IVD validation activities in alignment with company strategy, including related technical documentation (e.g., Performance Evaluation, IFU updates);Provides in-depth technical expertise to support and guide Product Development contributions to post-launch strategies.Conducts and oversees scientific literature reviews.Coordinates and leads a dedicated team, ensuring effective planning, task allocation, and alignment with project objectives, timelines, and regulatory requirements.Ensures effective management of technical interactions with Regulatory Affairs department during submission processes.
Education, Experience, and Qualifications
Scientific or a technical/biomedical University Master's degree.Minimum of two years of experience in IVD validation, ideally within a diagnostic or pharmaceutical company.Understanding of the mandatory regulatory requirements applicable to in vitro diagnostic medical devices.Planning, problem-solving, and cross-functional interaction skills are essential.Fluent in written and spoken Italian and English
Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.#J-18808-Ljbffr