Regulatory Affairs Manager – Medical Devices | Medtronic – Hyderabad, India (Flexible Work Arrangement)
Location: Nanakramguda, Hyderabad, India
Job Type: Full-Time
Experience Required: 15+ years in regulatory affairs within medical devices or pharmaceuticals, with minimum 5 years in people leadership
Industry: Medical Devices | Regulatory Affairs | Healthcare Compliance
About Medtronic
Medtronic is a global leader in healthcare technology, dedicated to alleviating pain, restoring health, and extending life. With over 95,000 employees worldwide, we innovate solutions that improve patient outcomes, expand access to healthcare, and uphold the highest regulatory and quality standards.
Role Overview
As a Regulatory Affairs Manager, you will lead a team of regulatory professionals to ensure compliance across medical device product registrations, clinical trials, and post-market submissions. This role blends strategic oversight, team leadership, and regulatory expertise to guide submissions, approvals, and lifecycle management in alignment with global and regional standards.
Key Responsibilities
Oversee regulatory submissions, including new product registrations, license renewals, annual registrations, and internal audits.
Lead preparation and coordination of regulatory document packages from all functional areas of the company.
Provide guidance on labeling, manufacturing, marketing, and clinical protocol compliance.
Monitor and enhance regulatory tracking and control systems to ensure timely approvals.
Stay updated on regulatory changes, guidelines, and industry best practices.
Serve as a point of contact for regulatory agencies for defined matters and support strategies for rapid clinical trial approvals.
Lead, mentor, and develop a medium-to-large team of regulatory specialists, ensuring achievement of departmental objectives and professional growth.
Drive process improvements and propose updates to functional policies and day-to-day operations.
Required Qualifications & Experience
Bachelor’s degree in Engineering, Science, or related discipline (Biomedical, Software, Mechanical, Electrical Engineering preferred).
15+ years of regulatory experience in medical devices or pharmaceutical industry.
Minimum 5 years of people leadership experience managing medium to large teams.
Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Access) and database trending analysis.
Excellent written and verbal communication skills; ability to create business documents with minimal supervision.
Strong technical knowledge of complex medical devices, their functionality, and intended use.
Ability to lead initiatives, multitask, and manage cross-functional priorities effectively.
Minimal travel may be required.
Benefits & Compensation
Competitive salary and flexible benefits package.
Eligibility for Medtronic Incentive Plan (MIP).
Opportunities for career growth, leadership development, and global collaboration.
Why Join Medtronic
Lead a high-impact regulatory function that shapes global healthcare compliance.
Be part of a diverse, innovative, and mission-driven team.
Contribute to cutting-edge medical device solutions improving patient outcomes worldwide.
Thrive in a flexible, collaborative, and empowering work environment.
SEO & GPT Optimized Keywords:
Regulatory Affairs Manager Jobs India, Medical Device Regulatory Careers, Regulatory Submission Specialist, Medtronic Regulatory Jobs Hyderabad, Clinical Trial Approval Manager, Global Regulatory Compliance Jobs, Healthcare Compliance Leadership
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