Home
Communities
Companies
- Companies
  
  Discover best places to work
- Compare Companies
  
  Compare & find best workplace
- Add Office Photos
  
  Bring your workplace to life
- Add Company Benefits
  
  Highlight your company's perks
Reviews
- Company reviews
  
  Read reviews for 6L+ companies
- Write a review
  
  Rate your former or current company
Salaries
- Browse salaries
  
  Discover salaries for 6L+ companies
- Salary calculator
  
  Calculate your take home salary
- Are you paid fairly?
  
  Check your market value
- Share your salary
  
  Help other jobseekers
- Gratuity calculator
  
  Check your gratuity amount
- HRA calculator
  
  Check how much of your HRA is tax-free
- Salary hike calculator
  
  Check your salary hike
Interviews
- Company interviews
  
  Read interviews for 40K+ companies
- Campus placements
  
  Interviews questions for 2K+ colleges
- Share interview questions
  
  Contribute your interview questions
Jobs
Awards

WINNERS AWAITED!
- ABECA 2025
  
  WINNERS AWAITED!
  
  AmbitionBox Employee Choice Awards - 4th Edition
- ABECA 2024
  
  AmbitionBox Employee Choice Awards - 3rd Edition
- AmbitionBox Best Places to Work 2022
  
  2nd Edition
- AmbitionBox Best Places to Work 2021
  
  1st Edition

For Employers

Add office photos

Engaged Employer

Abbott

Compare

4.1

based on 3k Reviews

Proud winner of ABECA 2024 - AmbitionBox Employee Choice Awards

Top Rated Pharma Company - 2024

233 Abbott Jobs

Regulatory Affairs Specialist

Abbott Healthcare Pvt. Ltd

4.1

based on 3k Reviews

1-6 years

New Delhi

1 vacancy

Regulatory Affairs Specialist

Abbott

posted 10d ago

Job Role Insights

Flexible timing

Key skills for the job

Software Configuration Management Salesforce Computer Networking Regulatory Affairs Medical Devices Audit Compliance

+ 1 more

Job Description

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

Employment Type: Full Time, Permanent

Read full job description

Prepare for Regulatory Affairs Specialist roles with real interview advice

What people at Abbott are saying

3.1

Rating based on 4 Regulatory Affairs Specialist reviews

Anonymous · Other in New Delhi

Likes

Opportunities are more to learn and go into new things. Work load is high that results in professional development.

Job security - Good

Dislikes

Work life balance is very low. Management have no empathy towards employees. Most of the employees are underpaid and no eveident increment and promotion ia there.