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Private Jobs / Private Sector
Abbott Hiring for Associate Manager Regulatory Affairs at New Delhi, India Full Time
Job Description
JOB DESCRIPTION: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
The 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 : 217-B 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)