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/A
In 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)
