Regulatory Specialist

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

Support the Regulatory Affairs Manager in the operative execution and control of the Regulatory Master Plan for US and Canada, regulatory projects and processes, in respect to the regulatory strategy of the company. Ensure regulatory support to Diasorin US RA Team.

Perform specific regulatory activities in compliance to the requirements defined in Diasorin procedures and regulations in force.

Key Duties and Responsibilities

Support the Regulatory Master Plan execution and monitoring (including management of extra-plans). Communicate, if required, with regulatory agencies regarding specific clarification and follow-up of the submissions under review.

Review Change Requests and Change Plans and assess the regulatory impact of product (assays and instruments) changes and help the manager to manage the related submissions.

Support to the Regulatory Affairs Manager in participating to project meetings in which the attendance of Regulatory is required.

Support the management of relations with Diasorin Sites and subsidiaries to ensure the update of regulatory requirements and GOPs, as applicable.

Work closely with product development, marketing and other teams to provide technical review of data or reports that will be incorporated into regulatory submissions, assuring scientific rigor, accuracy, and clarity of presentation.

Prepare registration dossiers to achieve timely regulatory approvals and maintenance of the existing Iicenses in US and Canadian markets and processes for which the RA input is needed (e.g. Innovation).

Coordinate, as required, activities related to regulatory projects led by Regulatory Affairs.

Keep under control applicable KPIs and prepare specific documents/report to highlight trend and risks.

Ensure the monitoring of local compliance with Corporate procedures and requirements, in collaboration with the Regulatory Affairs Manager.

Support the participation to tenders.

Education, Experience, and Qualifications 

University degree or a professional qualification of an equivalent or higher standard, preferably scientific and technical (Biology, Chemistry, Pharmacy, etc.). Master’s Degree is a plus.

Minimum 3 years in the same or similar role in an international context in the health care and science industry (preferably within diagnostic, medical devices or pharmaceutical areas).

Working knowledge of statutory and regulatory requirements applicable to in vitro diagnostics.

Working knowledge of quality assurance and regulatory affairs within a regulated environment.

Personal characteristics: integrity, ethics, confidentiality, diplomacy, open-mind, sense of observation, perspicacious, resolute, self-confident.

Excellent organizational (time management), analytical, and project management skills.

Excellent written and verbal communication, interpersonal skills, problem solving ability to allow diagnosis of problems, resolve key issues and follow through to resolution.

Big Attention to detail.

Sense of urgency.

Team work and collaboration with other individuals and functions.

Ability to manage relations with internal and external stakeholders.

Ability to adapt quickly to changing regulations.

Fluent spoken and written English. A second European language is a plus

Travels required as per geographies included in the job scope

What we offer

Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.

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.