Regulatory Affairs Specialist

Abbott

2 - 5 years

Delhi

Posted: 25/01/2025

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)/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

     

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

     

JOB FAMILY:

Regulatory Operations

     

DIVISION:

MD Medical Devices

        

LOCATION:

India > New Delhi : No. 100, 1st Floor, Okhla Industrial Estate, Phase III

     

ADDITIONAL LOCATIONS:

     

WORK SHIFT:

Standard

     

TRAVEL:

Not specified

     

MEDICAL SURVEILLANCE:

Not Applicable

     

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

     

     

     

About Company

Abbott is a global healthcare company developing medical devices, diagnostic tools, nutritional products, and medicines. It focuses on improving health outcomes across areas like heart disease, diabetes, and infectious diseases, with a strong emphasis on research and innovation.

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