Company: DiaSorin
Region: Saluggia , Piedmont
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 licenses 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.). Masters 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