Clinical Affairs Technical Specialist

Clinical Affairs Technical SpecialistPublished on: Jan 8, ****Job Category: Research & DevelopmentEmployment type: Regular Full TimeDiasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide.With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist".Why Join Diasorin?Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives.Your contributions will directly impact patient care, making a meaningful difference in the world.Global Reach & Innovation: Our work transcends borders.Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment.We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you.We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.Are you ready to be part of a dynamic team that's shaping the future of diagnostics?Join Diasorin and become a catalyst for change in the world of healthcare.Apply today and be a part of our exciting journey toward a healthier, more connected world.Together, we can make an impactJob ScopeWithin the assigned projects, he/she participates in all experimental testing activities for the verification and clinical validation of newly developed or existing immunodiagnostic products, in compliance with the established requirements, the assigned deadlines and the applicable Quality System procedures.Contributes to the planning, conduct and evaluation of clinical performance studies.Key Duties and ResponsibilitiesPerform experimental testing activities for the verification and validation of the clinical performance of newly developed immunodiagnostic products or existing products.Perform experimental testing on competitor products for the characterization of clinical samples and performance comparisons.Guarantee the proper conservation of clinical samples and the archiving of the related documentation, make them available for the execution of experimental tests or shipment to testing centers.Support the shipping activities of immunoassay prototypes to clinical validation centres, with the related documentation.Keep the Manager and the work team updated on the progress of the assigned activities, both from a technical point of view and about compliance with progress deadlines.Guarantee the correct compilation and availability of product documentation relating to the assigned activities.Collaborate in technical analyzes in the event of complaints and/or trends in non compliant performance.Carry out activities in the various phases of the project according to current laws, internal regulations, and external and internal Quality regulations.Collaborate in drafting protocols for clinical performance studies, in the analysis of results and in the drafting of final reports, for the verification and validation of clinical performances.Participate in activities necessary to initiate, conduct, and monitor clinical performance studies.Education, Experience, and QualificationsBachelor's degree or a professional qualification of an equivalent or higher standard, scientific and technical.Minimum 3 years work experience in the health care and science industry, preferably with diagnostic, medical devices or pharmaceutical Companies, with knowledge of relevant device technologies and related design processes.Knowledge of the legislation about the clinical performance of immunodiagnostic products.Ability to work independently while respecting roles.Ability to relate with external and internal interfaces.Good attitude to work in team.Ability to express oneself clearly verbally and in writing.Precision and attention to detail.Flexibility and proactiveness.Availability to travel (not extensively).Good spoken and written 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 or 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-*****-Ljbffr