RESPONSIBLE FOR + Execute strategies developed for regulatory approvals as per annual registration plans + Technical Evaluation of the dossiers and files and compilation for submission in India + Working cohesively with Business Unit on the additional requirements for the product approval, response to queries + Work with Labeling team to be compliant to India Specific labels as per local regulation + Manage Product Release Approval (PRA)/GTS Release post approvals after India Specific labels are released + Support Sales team with regards to any regulatory documents required for tender approval + Coordinate with India Marketing team + Prepare and submit all PSURS, PMS reports, Adverse Event Reports and other safety reports to the regulators + Regularly gets updated and self-trained with the latest regulations on Medical devices in the country + Networking and Liasioning with the Regulatory agencies both at centre and state level + Creates / 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 documentation + Support in Tracking emerging issues and identify solutions + Support Field Safety Corrective Action / Recall, Corrective & Preventive Actions (CAPA)& Stop Shipment + Support Internal & External Quality & Compliance Audits + Provide feedback on the new procedures (SOP or DOP) being developed by International quality & compliance team An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com