Regulatory Affairs Specialist

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