Regulatory Affairs Executive - Mumbai

Job description Provides regulatory guidance for IVDs, supports FDA/CE submissions, prepares and reviews documentation, assesses risks, ensures compliance, reviews clinical data and labeling, and liaises with regulatory bodies throughout the product lifecycle. Role: Regulatory Affairs Compliance Industry Type: Medical Devices & Equipment Department: Legal & Regulatory Employment Type: Full Time, Permanent Role Category: Corporate Affairs Education UG: B.Sc in Bio-Chemistry, Chemistry PG: MS/M.Sc(Science) in Bio-Chemistry, Chemistry, MBA/PGDM in Any Specialization Key Skills Skills highlighted with ‘‘ are preferred keyskills Ce MarkingMedical DevicesRegulatory AffairsIVDISO13485 Regulatory GuidelinesFDADiagnosticsSubmissionRegulatoryApprovalsLicensingRegulatory DocumentationRARegulatory SubmissionsCTDRegistrationRegulatory RequirementsISO DocumentationMdr