Regulatory Affairs Specialist

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/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)