Regulatory Affairs Specialist
Descrizione dell'offerta
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
- 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