Job Description

JOB DESCRIPTION:RESPONSIBLE FORExecute strategies developed for regulatory approvals as per annual registration plansTechnical Evaluation of the dossiers and files and compilation for submission in IndiaWorking cohesively with Business Unit on the additional requirements for the product approval, response to queriesWork with Labeling team to be compliant to India Specific labels as per local regulationManage Product Release Approval (PRA)/GTS Release post approvals after India Specific labels are releasedSupport Sales team with regards to any regulatory documents required for tender approvalCoordinate with India Marketing teamPrepare and submit all PSURS, PMS reports, Adverse Event Reports and other safety reports to the regulatorsRegularly gets updated and self-trained with the latest regulations on Medical devices in the countryNetworking and Liasioning with the Regulatory agencies both at centre and state levelCreates / develops regular checklists based on overall business regulatory plans as assigned.Support Evaluation of adequacy and compliance of systems, operations and practices against regulations and company documentationSupport in Tracking emerging issues and identify solutionsSupport Field Safety Corrective Action / Recall, Corrective & Preventive Actions (CAPA)& Stop ShipmentSupport Internal & External Quality & Compliance AuditsProvide feedback on the new procedures (SOP or DOP) being developed by International quality & compliance teamThe base pay for this position is N/AIn specific locations, the pay range may vary from the range posted.JOB FAMILY: Regulatory OperationsDIVISION: MD Medical DevicesLOCATION: India
New Delhi : No. 100, 1st Floor, Okhla Industrial Estate, Phase IIIADDITIONAL LOCATIONS:WORK SHIFT: StandardTRAVEL: Not specifiedMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott