Regulatory Affairs Assistant

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Regulatory Affairs Assistant

Title

Job

**Organizational Area**: Corporate QA &RA
Kind of contract

Facts

**Country / State**: Italy
- Full Time / Part Time: Full time

**Place of work**: Saluggia
- Permanent / Temporary: Temporary

**Home / Office based**: Hybrid work

**Legal Entity**: DiaSorin S.p.a

**Professional Family**: Quality & Regulatory

**Reporting To**: Corporate Regulatory affairs Manager - APAC, LATAM & Global Export

Job
YOUR MISSION

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.

Main
YOUR CONTRIBUTIONS

**Responsibilities**:

- 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**:
YOU

Experience

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

Personal Strengths
Master’s degree in regulatory is a plus.

Mobility

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

**Experience**: 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.

**Skills**:

- 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

**Languages**: fluent spoken and written English.

A second European language is a plus

**Travel availability**: N/A

**Relocation availability**: N/A

**Training required**: N/A