Abbott Hiring for Regulatory Affairs Specialist – Medical Devices

Abbott, a global leader in healthcare and medical devices, is seeking a skilled Regulatory Affairs Specialist to join our team in New Delhi, India. This is an exciting opportunity to contribute to ensuring compliance for innovative medical devices in India and international markets, supporting Abbott’s mission to improve lives through cutting-edge healthcare solutions.

Job Details

• Job Title: Regulatory Affairs Specialist – Medical Devices
• Location: New Delhi, India
• Department: Regulatory Affairs
• Reports To: Regulatory Affairs Manager

Job Summary

The Regulatory Affairs Specialist will play a critical role in ensuring that Abbott’s medical devices comply with regulatory requirements in India and global markets. This position involves preparing and submitting regulatory documents, maintaining compliance with the Central Drugs Standard Control Organization (CDSCO) and international standards, and providing regulatory guidance to cross-functional teams.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for product registrations, renewals, and amendments to CDSCO and other regulatory authorities.
• Ensure compliance with the Indian Medical Device Rules (IMDR) 2017 and its amendments.
• Liaise with regulatory agencies and notified bodies to secure approvals and manage audits.
• Monitor and communicate updates on regulatory requirements to internal stakeholders.
• Provide regulatory support during product development, clinical trials, and post-market surveillance.
• Maintain accurate regulatory files and tracking systems.
• Support internal and external audits and inspections.
• Collaborate with R&D, Quality Assurance, and Marketing teams to align on regulatory strategies.

Qualifications

• Education: Bachelor’s or Master’s degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field.
• Experience: 3–6 years in regulatory affairs within the medical device or pharmaceutical industry.
• Knowledge:
  • In-depth understanding of CDSCO regulations, CE marking, US FDA requirements, and ISO 13485 standards.
  • Experience with regulatory submissions and product lifecycle management.
• Skills: Strong communication, documentation, and organizational skills.

Preferred Skills

• Experience with regulatory submissions in India, Pakistan, Sri Lanka, and Bangladesh.
• Proficiency in regulatory software tools and document management systems.

Why Join Abbott?

• Global Impact: Work with a global healthcare leader operating in over 160 countries, delivering innovative medical devices that transform lives.
• Career Growth: Access opportunities for professional development in a supportive and innovative environment.
• Regulatory Excellence: Gain exposure to complex regulatory frameworks and contribute to compliance with global standards.

How to Apply

• Application Process: Interested candidates should submit their updated resumes to Abbott’s career portal or contact the HR team for further details.
• Location: Abbott India, New Delhi.

🔗Apply Here

Instructions:

• Include “Regulatory Affairs Specialist – Medical Devices” in the subject line of your application.
• Attach relevant educational certificates, experience documents, and a cover letter highlighting your regulatory experience.
• Candidates with experience in CDSCO and international regulatory submissions are preferred.

About Abbott

Abbott is a global healthcare leader dedicated to helping people live fuller, healthier lives. With a legacy of innovation in medical devices, diagnostics, nutrition, and pharmaceuticals, Abbott operates in over 160 countries and employs over 114,000 people worldwide.

Join our New Delhi team to contribute to cutting-edge medical device solutions that make a difference.

Join Abbott and help shape the future of healthcare through regulatory excellence!