Esperto per Certificazione dispositivi medici
Core
Expert in medical device certification and regulatory compliance, performing technical file analysis and on-site audits for manufacturers and notified bodies.
Role type
Medical Device Regulatory Certification Expert
Builds
Regulatory compliance documentation and certification for medical devices
Domain
Life Sciences / Medical Devices / Regulatory Affairs
Deliverable
client delivery
Required skills
Medical device regulation knowledge, technical file analysis, clinical evaluation, risk assessment, biological evaluation, audit execution, English (technical)
Preferred skills
Lead Auditor ISO 13485, Lead Auditor ISO 9000, Internal Auditor
Technologies
ISO 13485, ISO 9000, ISO 17025, ISO 17065
Responsibilities
Analyze technical files, conduct on-site audits at client facilities, perform clinical evaluations and risk assessments, support regulatory submissions
Seniority
Mid-level, hands-on IC