Medical Device Regulatory Jobs in India – Medtronic Careers

Medtronic is a global leader in healthcare technology, committed to alleviating pain, restoring health, and extending life. With over 95,000 employees worldwide, we innovate to solve the most challenging health problems. Our mission-driven culture fosters collaboration, equity, and career growth in a dynamic work environment.

Key Responsibilities

As a Regulatory Affairs Specialist II, you will:

• Support Design and Development Control activities to ensure compliance with global regulations.
• Prepare and file premarket submissions (US FDA, EU MDR, India CDSCO) for medical devices.
• Collaborate with cross-functional teams (R&D, Quality, Clinical) for regulatory strategy.
• Review pre-clinical & clinical protocols for regulatory compliance.
• Monitor changes in global regulatory policies and assess their impact.
• Assist in health agency inspections & notified body audits.
• Review labeling, advertising, and promotional materials for compliance.
• Maintain regulatory documentation and support change control assessments.

Qualifications & Skills

Minimum Requirements:

• Bachelor’s degree in Medicine, Engineering, Life Sciences, or related fields.
• 4-7 years of Regulatory Affairs experience in medical devices/pharma.
• Strong knowledge of US FDA, EU MDR, and India CDSCO regulations.
• Excellent communication, organizational, and project management skills.
• Ability to handle multiple tasks under pressure.
• Fluent in English (written & spoken).

Preferred Skills (Nice-to-Have):

• RAPS Regulatory Affairs Certification (RAC).
• Experience in global submissions (US, EU, APAC).
• Strong problem-solving and negotiation skills.
• Ability to work in a fast-paced, cross-functional environment.

Why Join Medtronic?

✅ Impact Lives: Contribute to life-changing medical innovations.
✅ Career Growth: Access to award-winning training & leadership programs.
✅ Flexible Work: Hybrid work model (Office + Remote).
✅ Competitive Salary & Benefits: Health insurance, retirement plans, and more.
✅ Inclusive Culture: Work with diverse, mission-driven professionals.

How to Apply?

Application Link