Manager Regulatory Affairs | Abbott – Medical Devices | Delhi

Job Description

• 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 the Labeling team to be compliant with 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 the 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 the center 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 identifying 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 the International Quality & compliance team