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Hiring companyMedtronic
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Regulatory Affairs Specialist
Gurgaon, Haryana, India Full-time Hybrid
About the role
Regulatory Affairs at Medtronic ensures compliance of medical device products with global and Indian regulations. The specialist prepares and submits regulatory dossiers, coordinates labeling changes, and interacts with agencies to secure approvals. Gurgaon, India, hybrid work model with on‑site collaboration.
What you’ll do
- Directs and prepares document packages for regulatory submissions
- Leads material compilation for license renewals and registrations
- Recommends labeling, manufacturing, and marketing changes for compliance
- Monitors and improves tracking/control systems
- Keeps abreast of regulatory procedures and changes
- Interacts with regulatory agencies on defined matters
- Advises strategies for clinical trial application approvals
What you’ll bring
- Baccalaureate degree in relevant field
- Minimum 2 years regulatory affairs experience or advanced degree with 0 years
Nice to have
- Knowledge of federal and local medical device regulations
- Experience with submission dossiers and licensing processes
Skills
Regulatory submissionsLabeling complianceDocumentation controlAgency interactionProcess improvement
Benefits
- Competitive salary
- Flexible benefits package
- Short‑term incentive plan
Education
Baccalaureate