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?
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