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Associate Manager

3 months ago

New Delhi, India Abbott Full time

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) 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