Location: Nanakramguda, Hyderabad, India (Flexible / Hybrid Work Model)
Company: Medtronic
Job ID: R60910
Employment Type: Full-Time
Experience Required: 15+ Years (Not suitable for freshers)
About the Company
Medtronic is a global leader in healthcare technology, committed to improving patient outcomes and expanding access to quality care worldwide. With a strong mission to alleviate pain, restore health, and extend life, Medtronic empowers innovation across the medical device and pharmaceutical landscape.
Job Overview
The Regulatory Affairs Manager will lead regulatory strategy, submissions, and compliance initiatives for complex medical devices and healthcare products. This is a leadership role requiring deep expertise in global regulatory frameworks, team management, and cross-functional collaboration to drive successful product approvals and lifecycle management.
Key Responsibilities
Lead preparation, review, and submission of regulatory documentation across global markets
Manage regulatory submissions, license renewals, and annual registrations
Recommend strategic changes to labeling, manufacturing, marketing, and clinical protocols to ensure compliance
Oversee regulatory tracking systems and ensure process efficiency and compliance accuracy
Stay updated with evolving regulatory guidelines and industry standards
Interface with regulatory authorities and manage communications on key submissions
Develop strategies to accelerate clinical trial approvals and regulatory clearances
Collaborate with Clinical, Quality, Manufacturing, and Pharmacovigilance teams
Ensure compliance with global regulatory requirements and internal SOPs
Leadership & People Management Responsibilities
Lead and manage a team of regulatory professionals, ensuring performance excellence and team development
Drive talent development through mentoring, coaching, and performance management
Define team goals, conduct performance reviews, and ensure alignment with organizational objectives
Foster a collaborative and inclusive work environment
Oversee operational planning, prioritization, and execution of regulatory projects
Autonomy & Organizational Impact
Provide operational and strategic leadership within the regulatory function
Make decisions impacting timelines, resource allocation, and regulatory outcomes
Drive continuous improvement initiatives across regulatory processes
Solve complex regulatory challenges through data-driven analysis and strategic thinking
Communication & Stakeholder Management
Engage with internal stakeholders, external partners, and regulatory agencies
Influence decision-making through strong communication and negotiation skills
Represent regulatory function in cross-functional and external discussions
Required Qualifications & Skills
Bachelor’s degree in Engineering, Life Sciences, or related field (Biomedical, Mechanical, Electrical preferred)
15+ years of experience in Regulatory Affairs within medical devices or pharmaceutical industry
Minimum 5 years of leadership experience managing mid to large-sized teams
Strong knowledge of global regulatory frameworks and submission processes
Proficiency in Microsoft Office tools and regulatory data analysis
Excellent written and verbal communication skills
Strong analytical, multitasking, and problem-solving abilities
Ability to understand complex medical device functionality and regulatory implications
Willingness to travel as required
Benefits & Compensation
Competitive salary and performance-based incentives
Eligibility for Medtronic Incentive Plan (MIP)
Comprehensive benefits package supporting career growth and personal well-being
Opportunities for global exposure and leadership development
Why Join Medtronic
Work with a global leader in healthcare innovation
Contribute to life-saving technologies and impactful healthcare solutions
Collaborate with a diverse, high-performing global workforce
Be part of a mission-driven organization shaping the future of healthcare
Important Note for Applicants
This is a senior leadership role requiring extensive experience in regulatory affairs. Freshers and early-career professionals are advised to explore entry-level roles such as Regulatory Affairs Associate, Drug Safety Associate, or Clinical Research positions to build foundational experience.
How to Apply
Interested candidates can apply through the official careers portal of Medtronic.
For more verified global pharmaceutical and clinical research job opportunities, visit ThePharmaDaily.com
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