Regulatory Affairs Manager
Location: Nanakramguda, Hyderabad, India
Work Arrangement: Flexible / Hybrid
Job Type: Full-Time
Job Requisition ID: R56573
Posted: 9 Days Ago
Industry: Medical Devices / Healthcare Technology / Pharmaceuticals
About the Role
Medtronic is seeking an experienced Regulatory Affairs Manager to provide regulatory leadership and people management support within a global healthcare technology environment. This role is critical in driving regulatory compliance, submission excellence, and strategic regulatory planning for complex medical devices and healthcare solutions.
The position combines hands-on regulatory expertise with people leadership, supporting operational, tactical, and selected strategic initiatives while enabling timely regulatory approvals across global markets.
Key Responsibilities
Regulatory Strategy & Submissions
Lead and coordinate preparation, review, and submission of regulatory documentation across multiple functions.
Oversee regulatory submissions, license renewals, and annual registrations in alignment with global and local regulations.
Recommend regulatory-compliant changes to labeling, manufacturing processes, marketing materials, and clinical protocols.
Develop strategies to support the earliest possible approval of clinical trial applications.
Compliance & Regulatory Intelligence
Monitor global regulatory procedures, evolving guidelines, and policy changes.
Ensure continuous improvement of regulatory tracking and control systems.
Support and participate in internal audits, health authority inspections, and regulatory inquiries.
Serve as a regulatory point of contact with health authorities on defined matters.
People & Team Leadership
Lead, mentor, and manage a team of experienced regulatory professionals.
Set performance goals, conduct reviews, provide coaching, and drive professional development.
Ensure alignment of team objectives with departmental and organizational priorities.
Foster a culture of accountability, collaboration, inclusion, and continuous improvement.
Operational & Organizational Impact
Establish operational plans and implement regulatory policies and processes.
Drive consistency, quality, and efficiency in regulatory deliverables.
Influence program timelines, customer satisfaction, and allocation of resources.
Proactively identify and resolve complex regulatory challenges requiring detailed analysis.
Communication & Stakeholder Management
Communicate effectively with internal stakeholders, external partners, vendors, and regulatory authorities.
Influence outcomes through expert guidance, negotiation, and cross-functional collaboration.
Support regulatory alignment across R&D, Manufacturing, Quality, Clinical, and Commercial teams.
Required Qualifications & Experience
Bachelor’s degree in Engineering or Science (Biomedical Engineering, Mechanical Engineering, Electrical Engineering, Software Engineering, or related disciplines preferred).
15+ years of regulatory affairs experience within the medical device, healthcare technology, or pharmaceutical industry.
Minimum 5 years of people management experience, leading medium to large regulatory teams.
Strong knowledge of global regulatory frameworks and medical device regulations.
Proven ability to interpret and apply regulatory requirements for complex medical devices.
Proficiency in Microsoft Word, Excel, PowerPoint, Access, and database trend analysis tools.
Strong business writing, documentation, and technical communication skills.
Ability to lead initiatives independently, manage multiple priorities, and operate in a fast-paced environment.
Willingness to travel minimally, as required.
Leadership & Autonomy
Manages professionals who operate with significant independence.
Provides tactical and operational leadership while supporting strategic initiatives.
Receives objectives in goal-oriented terms and determines execution approach.
Plays a key role in shaping regulatory operations and functional process improvements.
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package, designed to support employees across all career and life stages. Benefits include:
Market-aligned compensation
Flexible work arrangements
Health and wellness programs
Professional development and leadership growth opportunities
This position is also eligible for a short-term incentive under the Medtronic Incentive Plan (MIP).
About Medtronic
Medtronic is a global leader in healthcare technology, driven by a mission to alleviate pain, restore health, and extend life. With a global workforce of over 95,000 employees, Medtronic combines engineering excellence, innovation, and purpose to address the world’s most complex health challenges.
From research and development to manufacturing and global operations, Medtronic empowers its teams to engineer solutions that make a meaningful difference in patients’ lives worldwide.
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