Ehs Product Compliance Senior Specialist

Diasorin; Italia; In loco; EUR 38.000 - 47.000; Tempo pieno

Vantaggi offerti da questo lavoro

Canteen gratuita

Work wellbeing program

Pensione integrativa e assicurazione

Descrizione del lavoro

Diasorin cerca un EHS Product Compliance Senior Specialist in Italia per garantire la conformità regolatoria dei kit diagnostici, con particolare attenzione a SDS, etichette di sicurezza e documentazione correlata, in un contesto internazionale.

Responsabile dell’interpretazione di REACH, CLP e GHS e del supporto a siti Immuno, R&D, QA, Regulatory Affairs per una gestione coordinata della sicurezza chimica lungo tutto il ciclo di vita del prodotto.

Competenze

• Consolidata esperienza nella redazione e gestione di SDS e conformità di prodotto.
• Conoscenza approfondita REACH, CLP e GHS e capacità di applicarli ai dispositivi diagnostici.

Mansioni

• Redigere, revisionare e aggiornare SDS/MSDS in conformità a REACH, CLP, GHS e requisiti nazionali/internazionali.
• Garantire coerenza e armonizzazione globale di SDS e documentazione di prodotto per mercati EU e non EU.
• Gestire dossiers di sostanze chimiche, registrazione e comunicazione ad autorità competenti quando richiesto.
• Collaborare con R&D, QA, Regulatory Affairs, Manufacturing e Marketing per informazioni tecniche e di sicurezza lungo tutto il ciclo di vita del prodotto.

Conoscenze

Italiano (madre)

Inglese (fluente)

Formazione

Laurea in Chimica/Biologia/Biotech/Farmacia

Strumenti

SmartSolve

Simonsoft

SAP

Alfagest

Descrizione del lavoro

EHS Product Compliance Senior specialist

Salary : €42,700 monthly

Azienda : Diasorin Tipo Lavoro : Full Time Italy

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

• The EHS Product Compliance Senior Specialist is responsible for ensuring chemical regulatory compliance of Diasorin diagnostic kits, with particular reference to Safety Data Sheets (SDS), safety labels, and related documentation.
• The role ensures that applicable regulatory requirements (including REACH, CLP, and GHS) are properly interpreted and implemented, guaranteeing product compliance throughout the entire lifecycle and across different target markets.
• The position operates in an international context, contributing to the definition and implementation of global standards for SDS and labeling, and supporting Immuno platform sites in ensuring their consistent adoption.
• The role collaborates with key company functions (R&D, Quality Assurance, Regulatory Affairs, Manufacturing) to ensure a coordinated and consistent approach to chemical safety management and product compliance.

Key Duties and Responsibilities

• Draft, review, and update Safety Data Sheets (SDS/MSDS) for Diasorin diagnostic kits and reagents, ensuring full compliance with REACH, CLP, and GHS regulations, as well as applicable national and international requirements.
• Ensure regulatory consistency and global harmonization of SDS and product documentation across target markets (EU and non ‑ EU), contributing to the definition of common standards and templates, and supporting Immuno division sites in their correct and consistent implementation.
• Prepare, maintain, and update regulatory documentation supporting diagnostic kits (e.g., SDS, IFU, labels, declarations of conformity), ensuring full compliance of safety labeling (IVDR, CLP/GHS) and consistency among SDS, IFU, and labeling across different markets.
• Manage and maintain dossiers of chemical substances used in products, including registration, notification, and communication activities with ECHA and other Competent Authorities, where required.
• Act as the company’s technical-regulatory reference for chemical safety and product compliance topics.
• Proactively monitor regulatory developments (e.g., REACH, CLP, SVHC, PFAS, POPs, RoHS), assess their impact on products, and promptly implement necessary updates to technical and regulatory documentation using a risk‑based approach.
• Contribute to the definition, implementation, and continuous improvement of company processes related to the management of SDS and product regulatory documentation.
• Contribute to monitoring compliance and harmonization performance (e.g., SDS updates, labeling alignment, audit outcomes), supporting continuous process improvement.
• Collaborate with R&D, Quality Assurance, Regulatory Affairs, Manufacturing, and Marketing to collect, verify, and manage technical and safety information throughout the entire product lifecycle.
• Provide specialist support during internal audits, certification audits, and Authority inspections, ensuring the availability and traceability of required documentation.
• Contribute to coordinating product compliance activities at cross‑site level, promoting alignment among different sites, sharing best practices, and managing any deviations.
• Use and manage company information systems dedicated to regulatory and compliance documentation (e.g., SmartSolve, Simonsoft, SAP, Alfagest), ensuring data accuracy, currency, and integrity.

Education, Experience, and Qualifications

• Degree in a scientific discipline (Chemistry, Biology, Biotechnology, Pharmacy, or related fields).
• Preferably 2–3 years of experience in similar roles within the IVD, pharmaceutical, or chemical industry.
• Proven experience in drafting and managing Safety Data Sheets (SDS) and in chemical product compliance within regulated environments.
• In-depth knowledge of REACH, CLP, and GHS regulations, with the ability to interpret requirements and apply them operationally to products.
• Ability to integrate SDS with product documentation and within the regulatory framework of diagnostic devices (e.g., IVDR, ISO 13485).
• Competence in assessing the regulatory impact of new restrictions and regulatory updates (e.g., SVHC, PFAS, POPs, RoHS) on existing products and new developments.
• Experience acting as a technical reference for chemical safety topics, collaborating with cross‑functional teams (R&D, Quality, Regulatory, EHS).
• Excellent technical writing skills in English and familiarity with document management systems and regulatory software.
• Experience gained in IVD, Pharma, or Chemical environments is considered a plu
• Strong communication and organizational skills.
• Proactivity and quality‑oriented mindset.
• Ability to manage deadlines and priorities in regulated environments.
• Native Italian and fluent English.

What We Offer

• Permanent employment contract
• Classification under the Chemical-Pharmaceutical CCNL (Italian national collective bargaining agreement)
• Gross annual base salary from € 42.700,98
• 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] .