Competitive salary; short-term incentive via medtr...
Medical device regulatory compliance
Cdsco and local agency submissions
Clinical trial application management
The role involves leading the preparation, submission, and follow-up for product registrations and renewals across the Indian Sub-Continent
Job Summary
The role involves leading the preparation, submission, and follow-up for product registrations and renewals across the Indian Sub-Continent.
Candidates will interpret federal and local regulations to ensure compliance for medical devices while coordinating with global teams and business units.
Medtronic offers a competitive salary, flexible benefits package, and eligibility for the Medtronic Incentive Plan (MIP).
Matching Summary
The role involves leading the preparation, submission, and follow-up for product registrations and renewals across the Indian Sub-Continent.
Salary
Competitive Salary; Short-term incentive via Medtronic Incentive Plan (MIP); Flexible Benefits Package
Skills & Requirements
Must-have
Medical device regulatory compliance
CDSCO and local agency submissions
Clinical trial application management
Post-approval change control assessment
Quality Management System implementation
Nice-to-have
Excellent verbal communication skills
Ability to establish agency credibility
Self-motivated with positive attitude
Strong time management capabilities
Diplomatic and energetic personality
Key Requirements
B Pharm / M Pharm or Bio-Medical Engineering degree
5-7 years experience in pharma/medical device industry
2-3 years specific medical device regulatory affairs experience
Knowledge of CDSCO, FDA, CE regulatory requirements