Regulatory Affairs Specialist

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

Descrizione del lavoro

A medical device company in Alessandria is seeking a full-time Regulatory Affairs Specialist. The role involves supporting regulatory processes and compliance activities in a structured environment. Ideal candidates will have a Bachelor’s in a biomedical field and over 2 years of experience in the medical device sector along with strong organizational skills. This role offers an on-site position in Italy.

Competenze

• 2+ years in Regulatory Affairs, Quality Assurance, or Product Compliance in the medical device / pharma field.

Mansioni

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

ISO 13485

ISO 9001

MDR

FDA

CFDA

TGA

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.