Regulatory Affairs Intern
On-site · Rome, Lazio, Italy
Job Summary
Regulatory Affairs Intern at STERIS supports EU regulatory activities including CE marking submissions and NB submissions, aligning with EU MDR requirements and international standards (ISO 13485, ISO 9001, ISO 14971). Responsibilities include maintaining regulatory documentation for CE marking, assisting in regulatory change control, updating GSPR checklists, preparing and maintaining documentation for NB submissions and product registrations, monitoring submission timelines, and supporting audits/inspections (including for the Italian facility). The role involves collaboration with Regulatory Affairs staff and external stakeholders, and requires strong organizational, interpersonal, and written/oral communication skills in Italian and English. A Bachelor’s degree inEngineering or Biological Science and proficiency with Microsoft Office are required or preferred. Location: Rome, Italy; on-site work (IN_PERSON).
Required Qualifications
- Bachelor's Degree in Engineering General or Biological Science
- Excellent PC skills, including Microsoft Office applications
- Italian mother tongue and English fluent are mandatory
- Training course in Regulatory Affairs (preferred)
- Strong interpersonal skills – ability to work closely with people at all levels within the STERIS organization and facilitate the implementation of corrective action; able to work effectively and professionally with external people
- Strong oral and written communication skills.
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