Job Title: Regulatory Affairs Specialist
Job Requisition ID: R50190
Location: Nanakramguda, Hyderabad, India
Work Arrangement: Flexible / Hybrid
Job Type: Full-Time
Experience Required: 4–8 Years
Industry: Medical Devices | Regulatory Affairs | Healthcare Technology
Medtronic is a global leader in healthcare technology, dedicated to addressing the most complex health challenges worldwide. With a mission to alleviate pain, restore health, and extend life, Medtronic empowers innovation through engineering excellence, collaboration, and a strong commitment to healthcare access and equity. The organization offers a dynamic environment where professionals can build long-term careers while making a meaningful global impact.
Medtronic is seeking a skilled Regulatory Affairs Specialist to support regulatory submission activities, compliance initiatives, and interactions with regulatory authorities. This role involves end-to-end coordination of regulatory documentation, lifecycle management activities, and continuous monitoring of regulatory changes to ensure compliance across product portfolios. The position is ideal for professionals with experience in regulatory affairs within medical devices or healthcare technology environments.
Coordinate and prepare regulatory submission dossiers, including documentation for approvals, renewals, and annual registrations
Compile and review materials required for regulatory submissions, internal audits, and regulatory inspections
Recommend regulatory-compliant changes related to labeling, manufacturing, marketing, and clinical protocols
Monitor, maintain, and improve regulatory tracking and control systems
Stay current with global regulatory requirements, procedures, and evolving guidelines
Support and participate in interactions with regulatory agencies on defined matters
Contribute to regulatory strategies aimed at achieving timely approvals for clinical trial applications and product registrations
Work independently on moderately complex regulatory projects while collaborating with cross-functional stakeholders
4–8 years of hands-on experience in Regulatory Affairs, preferably within medical devices or healthcare technology
Strong understanding of regulatory submission processes, audits, and inspections
Experience supporting regulatory strategy, compliance, and lifecycle management activities
Ability to interpret and apply global regulatory guidelines and standards
Strong analytical, documentation, and problem-solving skills
Effective written and verbal communication skills
B.Tech (Mandatory)
Advanced education combined with relevant regulatory affairs experience is required
Individual contributor role within the Specialist Career Stream
Ability to work independently with general supervision on moderately complex assignments
May mentor or guide junior or entry-level professionals
Contributes to cross-functional projects and regulatory milestones
Competitive salary and comprehensive benefits package
Flexible work arrangements to support work-life balance
Eligibility for the Medtronic Incentive Plan (MIP)
Access to professional development resources and global career growth opportunities
Be part of a mission-driven organization impacting global healthcare outcomes
Work in a collaborative, innovation-focused environment
Build a long-term career with exposure to global regulatory and healthcare technology projects
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