Join Abbott as a Regulatory Affairs Specialist – Medical Devices in New Delhi. Apply now to ensure compliance, global submissions & shape the future of healthcare.
🏥 Abbott Careers: Hiring Regulatory Affairs Specialist – Medical Devices | New Delhi Jobs 2025
Abbott, a global leader in healthcare and life-changing medical technologies, is inviting applications for the position of Regulatory Affairs Specialist – Medical Devices at its New Delhi location. This role is ideal for experienced regulatory professionals looking to work at the forefront of medical device innovation and ensure compliance across India and international markets.
If you’re passionate about regulatory excellence and want to shape the future of healthcare, this opportunity with Abbott’s Regulatory Affairs team offers a platform for meaningful career advancement.
📌 Job Overview
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Job Title: Regulatory Affairs Specialist – Medical Devices
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Location: Abbott India, New Delhi
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Department: Regulatory Affairs
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Reporting To: Regulatory Affairs Manager
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Job Type: Full-Time
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Industry: Medical Devices / Healthcare / Regulatory Compliance
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Seniority Level: Mid-Senior Level
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Apply Here: Apply Now – Abbott Careers
📄 Job Summary
As a Regulatory Affairs Specialist, you will play a critical role in ensuring the regulatory compliance of Abbott’s medical device portfolio. From product registrations to post-market surveillance and cross-functional collaboration, you’ll support the company’s mission to deliver safe and effective medical technologies to patients worldwide.
🔍 Key Responsibilities
📁 Regulatory Documentation and Submissions
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Prepare, compile, and submit regulatory dossiers for new product registrations, amendments, and renewals to CDSCO and other global authorities.
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Maintain up-to-date knowledge of the Indian Medical Device Rules (IMDR), 2017 and ensure organizational compliance.
🌐 Regulatory Compliance and Liaison
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Serve as a regulatory liaison between Abbott and authorities such as CDSCO, US FDA, CE Notified Bodies, and local regulatory agencies.
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Manage audits and regulatory inspections, ensuring prompt resolution of issues.
🧩 Cross-Functional Regulatory Support
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Provide regulatory guidance during product development, clinical trials, and post-marketing activities.
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Collaborate with R&D, QA, Supply Chain, and Marketing teams to align strategies with regulatory requirements.
🗃️ Document Management and Systems
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Maintain comprehensive regulatory tracking systems, internal databases, and documentation in compliance with ISO 13485.
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Support the implementation of regulatory software tools and document control systems for increased efficiency.
🎓 Qualifications & Skills
✅ Education:
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Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biomedical Engineering, or related fields.
✅ Experience:
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3–6 years in Regulatory Affairs within the Medical Devices or Pharmaceutical industry.
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Prior experience working with CDSCO, and exposure to international regulatory frameworks (CE marking, US FDA, etc.).
✅ Knowledge & Compliance:
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Familiarity with:
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Indian Medical Device Rules (IMDR) 2017
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CE Technical Files and US FDA 510(k)/PMA submissions
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ISO 13485 and ISO 14971
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IVD/GMDN/UDI-related regulations
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✅ Soft Skills:
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Strong organizational, analytical, and documentation skills
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Excellent written and verbal communication
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Ability to work effectively in cross-functional teams
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Detail-oriented with problem-solving capabilities
🌍 Preferred Skills & Regional Exposure
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Prior experience in regulatory submissions across India, Pakistan, Sri Lanka, and Bangladesh.
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Proficiency in regulatory document management tools and e-submission platforms.
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Understanding of risk classification, product life cycle, and change management processes for medical devices.
🌟 Why Choose Abbott?
🧬 1. Global Healthcare Leader
With over 114,000 employees across 160 countries, Abbott is dedicated to helping people live healthier lives. This is your chance to be part of a company that delivers trusted medical devices, diagnostics, nutrition, and branded pharmaceuticals.
🚀 2. Innovative, Impactful Work
Work in a role where your contributions are critical in bringing innovative, life-saving devices to global markets. From diabetes management to cardiovascular health, Abbott is redefining medical technology.
📈 3. Career Growth & Development
At Abbott, professional development is a priority. Gain exposure to international regulations, audits, and cross-border product launches. Leverage internal training and mentorship programs to grow in your career.
📋 4. World-Class Regulatory Experience
Learn and grow in a regulatory environment that complies with global agencies like the US FDA, TGA, EMA, and CDSCO. Be audit-ready, inspection-resilient, and future-focused.
📤 How to Apply
Interested candidates should apply directly via Abbott’s official career portal or send a resume to the HR team (if mentioned).
🔗 Apply Online: Abbott Job Link
📧 Application Instructions:
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Use the subject: “Application – Regulatory Affairs Specialist – Medical Devices”
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Attach:
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Updated Resume
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Educational Certificates
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Work Experience Proofs
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Cover Letter highlighting relevant regulatory experience
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📌 Job Location
📍 Abbott India
New Delhi, India
Well-connected, central office location with a modern, collaborative workspace supporting cross-functional interaction.
🏢 About Abbott
Founded in 1888, Abbott is a global healthcare company committed to advancing health through innovative medical solutions. From diagnostics and devices to nutritional and branded generic medicines, Abbott touches the lives of millions of patients every day.
🌐 Global Presence:
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Operates in over 160 countries
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Products spanning diabetes care, cardiovascular, neuromodulation, diagnostics, and more
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Leader in regulatory excellence, product innovation, and market expansion.
✅ The Regulatory Affairs Specialist – Medical Devices role at Abbott, New Delhi, is a high-impact position ideal for candidates who are meticulous, strategic, and well-versed in global compliance frameworks.
If you’re ready to take your career to the next level in one of the world’s most reputable healthcare companies, don’t miss this opportunity.
👉 Apply Today: Submit your application via Abbott Careers
Shape the future of healthcare compliance with Abbott. Because at Abbott, what you do every day matters.
