Regulatory Affairs Specialist

CID; Venezia; In loco; EUR 50.000 - 70.000; Tempo pieno

Descrizione del lavoro

A medical device manufacturer in Italy is seeking a full-time Regulatory Affairs Specialist to support regulatory processes in a structured environment. Responsibilities include managing registrations, collaborating with authorities, and reviewing compliance documentation. The ideal candidate has a degree in a Biomedical field and 2+ years of relevant experience. Fluent Italian and English are required, along with knowledge of regulatory standards such as ISO 13485. This role is on-site in Venice.

Competenze

• 2+ years in Regulatory Affairs, Quality Assurance, or Product Compliance in the medical device/pharma field.
• Technical knowledge of ISO 13485, ISO 9001, MDR, FDA, CFDA, TGA.

Mansioni

• Support registrations and approvals for commercialization of medical devices.
• Collaborate with distributors, consultants, and competent authorities worldwide.
• Review labels and packaging in line with current regulations.
• Ensure proper documentation management, submission, and archiving.
• Support internal departments in preparing technical regulatory documentation.

Conoscenze

Fluent in Italian

Fluent in English

Organization & precision

Flexibility / adaptability

Problem solving & result orientation

Formazione

Bachelor's degree in a Biomedical Field

Strumenti

Microsoft Office Suite

Descrizione del lavoro

CID S.p.A., a medical device manufacturing and selling company, is looking for a full-time Regulatory Affairs Specialist to join our Regulatory Affairs Team (On-site, Italy).

The resource, reporting directly to the CSRO, will support regulatory processes and compliance activities within a structured and international environment.

Responsibilities

• Support registrations and approvals for commercialization of medical devices (new, renewals, updates, modifications).
• Collaborate with distributors, consultants, and competent authorities worldwide.
• Review labels and packaging in line with current regulations.
• Ensure proper documentation management, submission, and archiving.
• Support internal departments in preparing technical regulatory documentation.

Qualifications

• Education: Bachelor’s degree in a Biomedical Field
• Languages: Fluent in Italian and English; other languages will be positively evaluated
• Experience: 2+ years in Regulatory Affairs, Quality Assurance, or Product Compliance in the medical device / pharma field
• Technical Knowledge: ISO 13485, ISO 9001, MDR, FDA, CFDA, TGA
• Proficient in Microsoft Office Suite

Soft Skills

• Organization & precision
• Flexibility / adaptability
• Problem solving & result orientation

Workplace

CID S.p.A., Via Crescentino SNC, 13040 SALUGGIA (VC), Italy

Contract type

Based on the candidate’s experience

Salary

Based on the candidate’s experience

This announcement is open to both genders, in accordance with laws 903 / 77 and 125 / 91, and to individuals of all ages and nationalities, in accordance with legislative decrees 215 / 03 and 216 / 03.