Regulatory Affairs Specialist

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

Descrizione del lavoro

A medical device manufacturing company in Cuneo is seeking a full-time Regulatory Affairs Specialist. The role involves supporting regulatory processes and ensuring compliance for medical devices. The ideal candidate has a Bachelor’s degree in a Biomedical field, 2+ years of experience in Regulatory Affairs, and is fluent in Italian and English. This position offers an on-site work environment and career growth opportunities.

Competenze

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

Overview

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.