Job Opportunity for Regulatory Affairs Specialist at Abbott – Apply before 25th July 2025

Job Title: Regulatory Affairs Specialist – Medical Devices

Department: Regulatory Affairs
Location: New Delhi
Industry: Pharmaceutical / Healthcare / Clinical Research
Job Type: Full-Time

About Abbott

Abbott is a global leader in healthcare, committed to improving lives through breakthrough innovations. With a presence in over 160 countries and a workforce of 109,000 professionals, our work impacts millions each day through our offerings in diagnostics, medical devices, nutritionals, and branded generic medicines.

Role Overview

As a Regulatory Affairs Specialist – Medical Devices, you will play a vital role in ensuring compliance with national and international regulations, including CDSCO, CE marking, and US FDA standards. This role supports product registration, lifecycle management, and helps maintain regulatory compliance across South Asia markets.

Key Responsibilities

• Prepare and submit regulatory dossiers (registrations, renewals, amendments) to CDSCO and other authorities.

• Ensure adherence to Indian Medical Device Rules (IMDR) 2017 and relevant updates.

• Coordinate with regulatory bodies and notified agencies for inspections and audits.

• Monitor global regulatory changes and update internal teams accordingly.

• Provide regulatory support during product development and post-marketing phases.

• Maintain accurate regulatory records and databases.

• Participate in cross-functional collaborations with QA, R&D, and Marketing teams.

Candidate Profile

• Education: B.Pharm / M.Pharm / Biomedical Engineering / Life Sciences or related discipline

• Experience: 3 to 6 years in regulatory affairs for medical devices or pharmaceuticals

• Regulatory Knowledge: Proficient in CDSCO, ISO 13485, CE marking, and US FDA regulations

• Regional Experience: Familiarity with submission procedures in India, Pakistan, Sri Lanka, and Bangladesh

• Skills:

  • Strong documentation and communication abilities

  • Proficiency in regulatory tools and document control systems

  • Proven ability to work collaboratively in cross-functional teams

Additional Information

• Application Deadline: 25th July 2025

• Functional Area: Medical Devices Regulatory Affairs

• Work Location: New Delhi

How to Apply

Interested candidates are encouraged to apply through Abbott’s official careers page or submit their resume via the designated application portal before the closing date.

Be part of a company that helps people live healthier, fuller lives—join Abbott today.