Coordinate, compile regulatory documentation of filing activities/post approval changes for submission to regulatory authorities Approval with all relevant regulators USFDAFormulate RA standards, policies to ensure that regulatory complianceRequired Candidate profileMust be from Life Sciences, have experience with USFDA, Compliance, ISO 13485, basic requirements of EU guidelines, medical device related regulations its requirements for approval, change management

Job descriptionCoordination, implementation, maintenance of QMS as per ISO13485Prepare and Control of QMS Documentation and liaise with external parties on matters relating to Quality Systems. Review Post Market Surveillance records & reportingRequired Candidate profileCandidate must have worked on regulatory part of diagnostics or IVD Must have experience is CDSCOShould be from lifesciences backgroundCAPA, OOS knowledge is must

Maintain materials/supplies to optimize productionDevelop , Manage Inventory at site and in factoryTo optimize supply chain operations, cost reduction, customer satisfactionUpdating pending order status, escalate orders to managementRequired Candidate profileCandidate must have experience in SCM for pharma or chemicals Must have handled inventory, dispatch and logistics