RA Specialist for Leading MNC Pharma Company based at BKC

Job Description:

• Position: RA Specialist
  
  
• Employment Type: Contractual – 1 Year - This is a 1-year contractual opportunity, with the selected candidate being on the payroll of Talisman HR Solutions Pvt. Ltd.Talisman HR Solutions has been a trusted partner of Abbott for 10+ years, making this a great opportunity to work with a reputed global healthcare organization while gaining valuable experience
  
  
• Working Days: 5 Days a Week (Monday to Friday)
  
  
• Working Hours: 8:30 AM – 5:00 PM

Role Overview

We are looking for an RA Specialist to manage regulatory registration activities for Medical Devices and In-Vitro Diagnostics (IVD) products in India through the SUGAM Registration System.

The role will involve supporting the Indian business team on regulatory matters, developing strategies to facilitate timely product approvals, and ensuring smooth and timely market entry.

Key Responsibilities

• Prepare and review regulatory submissions for new product registrations and renewals.

• Monitor product launch timelines and proactively identify and flag potential delays.

• Track changes in regulatory requirements and ensure compliance, particularly for IVD products.

• Represent the company in relevant regulatory and industry meetings.

• Maintain regular communication and coordination with Indian regulatory authorities.

• Review product labels and related materials to ensure regulatory compliance.

• Coordinate the timely submission and testing of products at NIB and other approved local testing laboratories.

• Coordinate with NIB regarding performance evaluation reports, invoice follow-ups, and relationship management.

• Support the business team in resolving regulatory queries and ensuring smooth product registration and approval processes.