Regulatory Affairs Assistant - Saluggia, Italy - ITA 2023-010

Job Title

Regulatory Affairs Assistant

Job Facts

Organizational Area
Country / State
Place of work
Home/Office based
Office based

Professional Family: 

  • Quality
Reporting To
Corporate Regulatory affairs Manager - APAC, LATAM & Global Export

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Job ID
ITA 2023-010

Job Scope

Your Mission

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.

Main Responsibilities

Your Contributions

Maintaining 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
Supporting execution of the Regulatory Master Plan, cooperating actively with the other Regulatory teams and external stakeholders
Working closely with product development, marketing and other teams ensuring strategy falls in line with regulatory requirements through the whole product lifecycle
Collaborating in keeping company informed of regulatory requirements, with a specific focus on international markets
Reviewing/Approving Change Requests and assess regulatory impact of product changes and manage/ supervise related submissions
Preparing/Supervising registration dossiers to achieve timely regulatory approvals and maintenance of the existing licenses in international markets
Reviewing/Approving proposed labeling for compliance with applicable regulations
Ensuring compliance with applicable EU and international law/standards
Supporting the participation to tenders
Supporting post-marketing vigilance activities

Qualifications Experience Personal Strengths Mobility

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 ).

Technical Competencies

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
Travel Availability
Relocation Availability
Training Required

Induction Program Once Hired


We Offer You

As per Company Policy