Regulatory Affairs Manager
Company: Medtronic
Job Requisition ID: R56573
Employment Type: Full-time
Work Arrangement: Flexible Work Arrangement
Location: Nanakramguda, Hyderabad, India
Posted: 30 days ago
Role Overview
The Regulatory Affairs Manager will lead a Regulatory Affairs team supporting global medical device regulatory activities at Medtronic Engineering & Innovation Center (MEIC).
The role combines people leadership, regulatory strategy, submission management, compliance, operational excellence, and talent development. The position will work closely with quality, engineering, clinical, manufacturing, commercial, and other global stakeholders to support medical device development and lifecycle management.
Limited domestic and international travel may be required.
Key Responsibilities
Lead and develop a Regulatory Affairs team responsible for:
Global regulatory submissions
Product registrations
Renewals
Regulatory compliance activities
Product lifecycle management
Oversee preparation, review, and coordination of regulatory documentation packages supporting product approvals and lifecycle activities.
Develop and execute regulatory strategies aligned with business objectives and applicable global regulatory requirements.
Partner with cross-functional teams including:
Quality
Engineering
Clinical
Manufacturing
Commercial
Ensure regulatory compliance throughout the medical device product lifecycle.
Monitor changes in global regulations, standards, and regulatory guidance and assess their potential business impact.
Drive continuous improvement initiatives focused on:
Regulatory processes
Documentation quality
Operational efficiency
Compliance tracking
Regulatory reporting systems
Provide leadership during regulatory inspections, audits, agency interactions, and compliance activities.
Manage:
Team performance
Resource planning
Talent development
Succession planning
Employee engagement
Required Qualifications
Bachelor's degree in:
Engineering
Biomedical Engineering
Life Sciences
Related scientific discipline
15+ years of Regulatory Affairs experience within the medical device or pharmaceutical industry.
Minimum 5 years of people leadership experience managing medium-to-large regulatory, quality, or compliance-focused teams.
Demonstrated experience with:
Regulatory submissions
Product registrations
Regulatory compliance
Regulatory lifecycle management
Working knowledge of global medical device regulatory requirements.
Experience interacting with regulatory agencies.
Strong verbal and written communication skills.
Ability to collaborate effectively with global cross-functional teams.
Preferred Qualifications
Advanced degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field.
Experience leading global Regulatory Affairs teams within a multinational medical device organization.
Demonstrated success in:
Process improvement
Operational excellence
Regulatory compliance initiatives
Experience supporting regulatory:
Inspections
Audits
International regulatory authority interactions
Strong analytical skills.
Experience using technology and reporting tools for:
Regulatory metrics
Regulatory tracking
Decision-making
Core Competencies
Medical Device Regulatory Affairs
Global Regulatory Strategy
Regulatory Submissions
Product Registration
Lifecycle Management
Regulatory Compliance
Regulatory Agency Interaction
Audit & Inspection Readiness
Quality & Compliance
Process Improvement
Operational Excellence
People Management
Resource Planning
Talent Development
Cross-functional Leadership
Regulatory Metrics & Reporting
Experience Level
This is a senior people-management and regulatory leadership position. The role is targeted at an experienced Regulatory Affairs professional with 15+ years of industry experience and at least 5 years of leadership experience.
The requirement for global medical device regulatory exposure makes this substantially more specialized than a general pharmaceutical Regulatory Affairs management role.
Location & Work Model
Nanakramguda, Hyderabad, India
Flexible Work Arrangement
Limited domestic and international travel may be required.
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package designed to support employees across different career and life stages.
The position is also eligible for the Medtronic Incentive Plan (MIP), a short-term incentive program.
Recruitment Fraud Alert
Medtronic advises candidates to apply only through official Medtronic recruitment channels. Legitimate recruiting communications use approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will not request payment or sensitive financial information during the early stages of recruitment.
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