Require Regulatory Affairs Specialist at Abbott - B.Pharm, M.Pharm Apply

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

Post : Regulatory Affairs Specialist – Medical Devices

Job Summary :
The Regulatory Affairs Specialist is responsible for ensuring that medical devices comply with all applicable regulations in India and international markets. This role involves preparing and submitting regulatory documents, maintaining compliance with CDSCO and other global regulatory bodies, and supporting product development teams with regulatory guidance.

Job Description
• Prepare, compile, and submit regulatory dossiers for product registrations, renewals, and amendments to CDSCO and other regulatory authorities.
• Ensure compliance with Indian Medical Device Rules (IMDR) 2017 and amendments.
• Liaise with regulatory agencies and notified bodies for approvals and audits.
• Monitor changes in regulatory requirements and communicate updates to internal stakeholders.
• Provide regulatory input during product development, clinical trials, and post-market surveillance.
• Maintain regulatory files and tracking systems.
• Support internal and external audits and inspections.
• Collaborate with cross-functional teams including R&D, Quality Assurance, and Marketing.

Candidate Profile
• Bachelor’s or Master’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or related field.
• 3–6 years of experience in regulatory affairs within the medical device or pharmaceutical industry.
• In-depth knowledge of CDSCO regulations, CE marking, US FDA, and ISO 13485.
• Experience with regulatory submissions and product lifecycle management.
• Strong communication and documentation skills.
• Experience with India, Pakistan, Sri Lanka, Bangladesh regulatory submissions.
• Proficiency in regulatory software tools and document management systems.

Additional Information
Experience : 3–6 years
Qualification : B.Pharm, M.Pharm
Location : New Delhi
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Medical Devices
End Date : 25th July 2025