Hiring for QA RA Manager with mininum 5 years of experience Required Attributes 5+ years in QA/RA within medical devices or IVD- Hands-on CDSCO submissions experience (Class B & C devices, MDR 2017)- Strong ISO 13485 QMS ownership and internal audit experience- Familiarity with EU IVDR (Technical Files, PER, Notified Body liaison) and/or WHO Prequalification is a strong plus- Experience with design controls, ISO 14971 risk management, and CAPA leadership-
Hiring for QA RA Manager with mininum 5 years of experience Required Attributes 5+ years in QA/RA within medical devices or IVD- Hands-on CDSCO submissions experience (Class B & C devices, MDR 2017)- Strong ISO 13485 QMS ownership and internal audit experience- Familiarity with EU IVDR (Technical Files, PER, Notified Body liaison) and/or WHO Prequalification is a strong plus- Experience with design controls, ISO 14971 risk management, and CAPA leadership-