Regulatory Affairs Specialist - Saluggia, Italy - ITA 2021-030

Job Title

Regulatory Affairs Specialist

Job Facts

Organizational Area
Corporate
Country / State
Italy
Place of work
Saluggia
Home/Office based
Office based

Professional Family: 

  • Quality
Reporting To
Senior Corporate Manager Regulatory Affairs Operations & China

Kind of contract

Full Time / Part Time
Full Time
Permanent / Temporary
Permanent
Job ID
ITA 2021-030

Job Scope

Your Mission

The Regulatory Affairs Specialist supports the execution of the Regulatory Master Plan for the assigned area in respect to the Regulatory strategy of the Company. He/she maintains compliance with relevant statutory requirements.

Main Responsibilities

Your Contributions
  • Supporting the execution of the Regulatory Master Plan, cooperating actively with the other Regulatory teams and external stakeholders
  • 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
  • Collaborating in keeping company informed of regulatory requirements and update of laws, regulations, and standards applicable to the IVD sector
  • Supporting in the assessment of regulatory impact of product changes and support the preparation of related submissions
  • Preparing registration dossiers to achieve timely regulatory approvals and maintenance of the existing licenses in international markets
  • Participating to projects, providing regulatory inputs and ensuring compliance with statutory requirements
  • Collaborating and manage relations with DiaSorin distributors and subsidiaries to the aim of guarantee the update of regulatory requirements and , when applicable, relevant GOPs
    Preparing and assembling regulatory documentation

Qualifications Experience Personal Strengths Mobility

You
Education
Master’s Degree
Specialization
Master’s Degree (or professional qualification of an equivalent or higher standard) in Biology, Chemistry, Pharmacy, Engineering, or equivalent scientific degrees A Master in regulatory affairs is a plus.
Experience

Minimum of 3/4 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

Working knowledge of quality assurance and regulatory affairs within a regulated environment. Microsoft Office

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. Fluency in second European Language is a plus
Travel Availability
N/A
Relocation Availability
N/A
Training Required

Induction Program Once hired

Benefits

We Offer You

As for Company policy