Regulatory Support Stream Leader

Diasorin 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 impact!

Job Scope

The Regulatory Support Stream Leader oversees Product Development Immuno department activities related to immunodiagnostic assays in order address requests from Notified Bodies during the submission process or license renewal of legacy products. The role includes both the responsibility of planning and the guaranteed executing IVD validation activities in compliance with the company strategies. It also involves conducting literature reviews, preparing technical documentation in compliance with the defined requirements, and providing internal expertise on the technical of the Product Development Department aspects of regulatory strategies.

Key Duties and Responsibilities

• This position ensures the technical and managerial leadership necessary to complete all activities in accordance with the different established regulatory demands, organizational objectives, and agreed timelines.
• S-He coordinates the activities of Technical Expert(s) and Laboratory Staff as a Team Leader.
• S-He may act as reference contact for Product Development Immuno department for activities in accordance with Regulatory departments intersite demands.
• S-He may act as the reference contact for the Product Development Immuno Department in activities carried out in collaboration with the QA Department, particularly those related to Post Market Surveillance and IVD R documentation updates (e.g., Performance Evaluation Documentation, IFU revisions).
• S-He maintains expertise of state-of-the-art technical requests coming from Notified Bodies in the different Countries
• S-He coordinates and monitors, in collaboration with the Project Management Office, the performance of assigned Activities.
• S-He verifies critical aspects and requirements in compliance with internal regulations (GOP-SOP) and external and internal quality standards.
• S-He guarantees the availability of the assigned Activities

Education, Experience, and Qualifications 

• Scientific University degree
• Minimum of two years of experience in IVD validation and/or Regulatory Affairs, ideally within Diasorin or in comparable diagnostic or pharmaceutical company.
• Strong understanding of the mandatory regulatory requirements applicable to in vitro Diagnostic Medical Devices
• 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.