02 Oct
|
Medtronic
|
Gurugram
02 Oct
Medtronic
Gurugram
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to put patients first — developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life
The Regulatory Affairs function is responsible for enabling patient access to Medtronic therapies by ensuring products meet applicable regulatory requirements throughout their lifecycle. This role supports Medtronic's medical device portfolio in India, partnering with global and local stakeholders to manage regulatory submissions, product registrations, license maintenance, post-approval changes, and compliance activities across multiple therapy areas.
The Senior Regulatory Affairs Specialist serves as the regulatory lead for assigned product portfolios, supporting market access, product lifecycle management,
and regulatory compliance across India. The role works closely with commercial, operational, clinical, and global regulatory teams to execute regulatory strategies, maintain licenses, and deliver timely approvals that support business objectives and uninterrupted product availability.
Primary Responsibilities
• Manage product registrations, import licenses, renewals, and post-approval change submissions for medical devices in India.
• Develop and execute regulatory strategies supporting current product introductions and lifecycle management activities.
• Interface with regulatory authorities including Central Drugs Standard Control Organization (CDSCO), State Food and Drug Administration (FDA) authorities, Bureau of Indian Standards (BIS), Department of Telecommunications (DoT), and Customs authorities.
• Prepare, review, and submit regulatory documentation to support product approvals, l
📌 Regulatory Affairs Specialist (Gurugram)
🏢 Medtronic
📍 Gurugram