Senior Regulatory Affairs Specialist
GurugramFull-time6–10 yrsPosted over a month ago
Senior pharma role at Medtronic in Gurugram. Needs 6–10 years and a B.Tech, B.E. or M.Pharm.
About the role
Careers that change lives start here. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
What you'll do
- The Senior Regulatory Affairs Specialist serves as the regulatory lead for assigned product portfolios, supporting market access, product lifecycle management
- The role works closely with commercial, operational, clinical, and global regulatory teams to execute regulatory strategies, maintain licenses
- Manage product registrations, import licenses, renewals, and post-approval change submissions for medical devices in India
- Develop and execute regulatory strategies supporting new product introductions and lifecycle management activities
- Interface with regulatory authorities including Central Drugs Standard Control Organization (CDSCO), State Food and Drug Administration (FDA) authorities
What you need
- Regulatory affairs
- Documentation
- Medication administration
- Sales
- Telecom