Regulatory Affairs Specialist
2 settimane fa
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.
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