Abbott Hiring Regulatory Affairs Specialist

Abbott Hiring Regulatory Affairs Specialist – New Delhi

Abbott, a global leader in healthcare and medical devices, is seeking an experienced Regulatory Affairs Specialist to join its team in New Delhi, India. If you have expertise in regulatory approvals, compliance, and medical device regulations, this is an excellent opportunity to advance your career with one of the most reputed healthcare companies in the world.

About Abbott

Abbott is a multinational healthcare company that develops innovative solutions in diagnostics, medical devices, nutrition, and pharmaceuticals. With a strong presence in India, Abbott is committed to delivering high-quality healthcare products while ensuring compliance with global and local regulatory standards.

Key Responsibilities

As a Regulatory Affairs Specialist, your responsibilities will include:

Regulatory Approvals & Compliance

• Execute regulatory approval strategies as per annual registration plans.
• Evaluate and compile dossiers and technical files for regulatory submissions in India.
• Ensure compliance with local labeling regulations in collaboration with the Labeling team.
• Manage Product Release Approvals (PRA) post-approval processes.
• Monitor and ensure compliance with Indian medical device regulations.

Stakeholder & Business Coordination

• Work closely with the Business Unit and Sales team to fulfill regulatory requirements for product approval.
• Provide necessary regulatory documents for tender approvals.
• Coordinate with the India Marketing team to align regulatory strategies with business objectives.
• Liaise with regulatory authorities at the central and state level.

Safety & Quality Assurance

• Prepare and submit PSURs (Periodic Safety Update Reports), PMS (Post-Market Surveillance) reports, and Adverse Event Reports.
• Support internal and external audits to maintain quality and regulatory compliance.
• Assist in Field Safety Corrective Actions (FSCA), Corrective and Preventive Actions (CAPA), and recall processes.
• Stay updated with emerging regulatory trends and policy changes.

Required Qualifications & Experience

Education:

• B.Pharm, M.Pharm, B.Sc, M.Sc in Life Sciences, Biotechnology, Microbiology, or related fields.

Experience:

• 2-5 years of experience in Regulatory Affairs within the pharmaceutical, medical device, or healthcare industry.
• Knowledge of Indian regulatory frameworks, medical device regulations, and global compliance standards.
• Experience with regulatory submissions, dossier compilation, and licensing processes.
• Strong understanding of labeling, quality assurance, and product safety requirements.

How to Apply?

Interested candidates can apply online through Abbott’s official careers page: 👉 Apply Now

Don’t miss this opportunity to advance your career with Abbott!

Job Summary Table

Location: New Delhi, India