Looking for high-paying Regulatory Affairs Specialist jobs in Gurgaon? Medtronic India is hiring experienced professionals for its Regulatory Affairs team in Gurugram. Candidates with B Pharma, M Pharma, Biomedical Engineering, or Life Sciences backgrounds and expertise in medical device regulatory affairs can apply for this hybrid opportunity.

This latest Medtronic Regulatory Affairs job is ideal for professionals experienced in CDSCO submissions, import licenses, clinical trial approvals, medical device registration, and regulatory compliance across India and neighboring countries.

Job Overview

Key Responsibilities

The selected candidate will manage end-to-end medical device regulatory affairs activities for the Indian subcontinent including India, Sri Lanka, Bangladesh, and Nepal.

Major Responsibilities Include:

• Preparation and submission of regulatory dossiers for product registrations and renewals
• Managing import licenses and regulatory approvals
• Coordination with global regulatory teams and local business units
• Tracking registration and re-registration applications
• Managing post-approval change controls and compliance activities
• Handling adverse event reporting and field actions
• Monitoring CDSCO and international regulatory updates
• Supporting marketing teams on tender-related compliance issues
• Managing regulatory documentation systems, SOPs, trackers, and archival
• Liaising with agencies including CDSCO, FDA, DGDA, State FDA, DoT, and AERB
• Supporting clinical trial submissions and approvals for medical devices

Eligibility Criteria

Candidates applying for this Regulatory Affairs Specialist job at Medtronic India should meet the following requirements:

Educational Qualification

• B Pharma
• M Pharma
• Bachelor’s or Master’s Degree in Biomedical Engineering
• Life Sciences or related Science disciplines
• Regulatory Affairs training preferred

Experience Required

• Minimum 5–7 years experience in pharma, medical devices, or life sciences
• At least 2–3 years experience in medical device regulatory affairs

Required Skills

• Knowledge of CDSCO regulations
• Medical device registration expertise
• Import license management
• Clinical trial regulatory approvals
• Regulatory compliance and quality systems
• Understanding of FDA and CE regulations
• Strong documentation and coordination skills

Why Join Medtronic?

Medtronic India is one of the world’s leading medical technology companies offering global exposure, advanced regulatory projects, and opportunities to work with cross-functional international teams.

Benefits of This Opportunity

• Hybrid work model
• Exposure to global medical device regulations
• Career growth in regulatory affairs
• Opportunity to work on clinical trial approvals and compliance management
• International regulatory coordination experience

How to Apply

Application Link