Regulatory Affairs Assistant

Diasorin; Saluggia; Ibrido; EUR 32.000 - 39.000; Tempo pieno

Vantaggi offerti da questo lavoro

Permanent contract

Base salary €35,200+ per year

Variable compensation tied to targets

Canteen facility

Descrizione del lavoro

DiaSorin is seeking a Diagnostics Regulatory Specialist to support the Regulatory Master Plan, ensuring compliance with EU and international regulations across the product lifecycle.

The role requires a Master’s in science (or regulatory) with 1–2 years of experience in international healthcare. Hybrid work in Italy is offered with a permanent contract and a base salary starting at €35,200 per year.

Competenze

• Master’s Degree in Biology, Chemistry, Pharmacy, Engineering or equivalent scientific degree.
• Master’s degree in regulatory is a plus.
• Knowledge of statutory and regulatory requirements for Medical Diagnostic Devices in vitro.
• 1–2 years experience in international healthcare/regulatory environment.

Mansioni

• Maintain compliance with statutory, regulatory and industry best practices (cGMP).
• Support execution of the Regulatory Master Plan with cross-functional teams.
• Collaborate with product development, marketing and other teams on regulatory strategy across product lifecycle.

Conoscenze

Regulatory affairs

Attention to detail

English proficiency

Formazione

Master’s Degree in Biology, Chemistry, Pharmacy, Engineering

Master’s degree in regulatory is a plus

Descrizione del lavoro

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry’s broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

Why Join Diasorin

• Build What Matters Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
• Grow in a People-Centered Culture Thrive in a culture that values accountability, inclusion, and continuous development.

Job Scope

Support execution of the Regulatory Master Plan for the assigned area in respect to the Regulatory strategy of the Company. Maintain compliance with relevant statutory requirements while ensuring regulatory support to the European DiaSorin Sites.

Key Duties And Responsibilities

• Maintain compliance with relevant statutory, regulatory and industry best practices cGMP requirements, to achieve and continuously improve quality which enhances and maximizes customer satisfaction with products and services provided by the Company
• Support execution of the Regulatory Master Plan, cooperating actively with the other Regulatory teams and external stakeholders
• Work closely with product development, marketing and other teams ensuring strategy falls in line with regulatory requirements through the whole product lifecycle
• Collaborate in keeping company informed of regulatory requirements, with a specific focus on international markets
• Review/Approve Change Requests and assess regulatory impact of product changes and manage/ supervise related submissions
• Prepare/Supervise registration dossiers to achieve timely regulatory approvals and maintenance of the existing licenses in international markets
• Review/Approve proposed labeling for compliance with applicable regulations
• Ensure compliance with applicable EU and international law/standards
• Support the participation to tenders
• Support post-marketing vigilance activities

Education, Experience, And Qualifications

Master’s Degree in Biology, Chemistry, Pharmacy, Engineering, or equivalent scientific degrees

Master’s degree in regulatory is a plus.

Knowledge of statutory and regulatory requirements applicable to the field of "Medical Diagnostic Devices" in vitro

1/2 years experience in the same or similar role within international context in the health care and sciences industry (preferably diagnostic, medical devices or pharmaceutical industry ).

Detailed 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

Time management

Good communication skills

Team Work And Collaboration With Other Individuals And Functions

Ability to manage relations with internal and external stakeholders

Attention to details

Sense of urgencies

Fluent spoken and written English.

A second European language is a plus

HYBRID WORK

What We Offer

• Permanent employment contract
• Classification under the Chemical-Pharmaceutical CCNL (Italian national collective bargaining agreement)
• Gross annual base salary from € 35.200,00
• Variable compensation linked to the achievement of objectives

Actual pay is set on objective criteria: seniority, distinctive skills, scope of responsibility.

At DiaSorin, we are committed to supporting the well-being of our employees every day — which is why we complement compensation with a comprehensive set of benefits:

• Free canteen
• Feel Good – DiaSorin for You: a dedicated well-being program offering initiatives, services, and opportunities designed to support you every day
• A benefits package guaranteed by the Chemical-Pharmaceutical CCNL, including a supplementary pension fund and supplementary healthcare coverage
• Company welfare plan offering flexible benefits you can tailor to your needs

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

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, disability, protected veteran status, or any other characteristic protected by applicable law.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.

Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact [e-mail].