Regulatory Affairs Specialist
Location: Nanakramguda, Hyderabad, India
Work Mode: Hybrid
Job Type: Full-Time
Experience Required: 4–8 Years
Job Requisition ID: R49996
Category: Regulatory Affairs / Medical Devices / Healthcare Technology
Role Overview
Medtronic is seeking a skilled Regulatory Affairs Specialist to support global regulatory submissions, compliance activities, and lifecycle management across medical device portfolios. This role plays a critical part in ensuring regulatory readiness, enabling timely approvals, and supporting innovation in healthcare technology.
The position is ideal for experienced regulatory professionals who can independently manage moderately complex projects while collaborating with cross-functional stakeholders in a hybrid work environment.
Key Responsibilities
Coordinate and prepare regulatory submission packages for global markets, including registrations, renewals, and amendments
Compile and review documentation required for regulatory submissions, internal audits, and health authority inspections
Support and recommend updates to product labeling, manufacturing processes, marketing materials, and clinical protocols to ensure regulatory compliance
Monitor, maintain, and enhance regulatory tracking and control systems
Stay current with evolving global regulatory requirements, standards, and procedures
Interact with regulatory authorities on defined submission and compliance matters
Contribute to regulatory strategies aimed at achieving early and efficient approvals for clinical trial applications and product registrations
Support cross-functional teams to meet project milestones and regulatory timelines
Required Qualifications
Education
Bachelor of Technology (B.Tech) – Mandatory
Professional Experience
4 to 7.9 years of hands-on experience in Regulatory Affairs, preferably within medical devices, healthcare technology, or regulated industries
Demonstrated experience managing regulatory submissions and documentation independently
Core Skills & Competencies
Strong working knowledge of regulatory submission processes and compliance requirements
Ability to manage multiple projects with minimal supervision
Excellent documentation, organizational, and analytical skills
Effective communication and collaboration skills with internal stakeholders
Experience contributing to process improvements and system enhancements
Familiarity with cross-functional collaboration and regulatory project workflows
Career Level & Impact
Individual contributor role within the Specialist Career Stream
Works independently on moderately complex assignments with general supervision
Contributes to project planning, execution, and milestone completion
May mentor or guide junior regulatory professionals
Supports cross-functional initiatives and continuous improvement efforts
Work Environment
Hybrid work model based in Hyderabad, India
Office-based role with collaboration across global teams
Compensation & Benefits
Competitive salary aligned with industry standards
Flexible benefits package designed to support professional and personal well-being
Eligibility for the Medtronic Incentive Plan (MIP), a short-term performance-based incentive
Access to career development resources and long-term growth opportunities
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 professionals, Medtronic combines engineering excellence with innovation to address the world’s most complex health challenges.
The company fosters an inclusive, purpose-driven culture where employees are empowered to explore, innovate, and make a meaningful impact on patient lives worldwide.
Equal Opportunity Statement
Medtronic is committed to providing equal employment opportunities and maintaining a diverse and inclusive workplace. All qualified applicants will be considered without discrimination, and reasonable accommodations are available throughout the recruitment process.
SEO Keywords Optimized
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