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Hiring companyMedtronic

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Regulatory Affairs Manager

Nanakramguda, Hyderabad, India Full-time On-site

About the role

Medtronic’s Engineering & Innovation Center (MEIC) in Hyderabad seeks a Regulatory Affairs Manager to lead global medical device regulatory activities. The role oversees team performance, drives regulatory strategies, and ensures compliance across the product lifecycle. This position is based in Nanakramguda, India, with a Flexible Work Arrangement model.

What you’ll do

  • Lead and develop a Regulatory Affairs team supporting global submissions and compliance
  • Oversee preparation, review, and coordination of regulatory documentation packages
  • Develop and execute regulatory strategies aligned with business objectives and global requirements
  • Partner with quality, engineering, clinical, manufacturing, and commercial teams for compliance
  • Monitor changes in global regulations and assess business impact
  • Drive continuous improvement initiatives for processes, documentation, and efficiency
  • Provide leadership during regulatory inspections, audits, and agency interactions
  • Manage team performance, resource planning, talent development, and succession planning

What you’ll bring

  • Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or related scientific discipline
  • 15+ years of regulatory affairs experience within medical device or pharmaceutical industry
  • Minimum 5 years of people leadership experience managing medium to large teams
  • Demonstrated experience supporting regulatory submissions, registrations, and lifecycle management
  • Working knowledge of global medical device regulatory requirements and agency interactions

Nice to have

  • Advanced degree in Engineering, Biomedical Engineering, Life Sciences, or Regulatory Affairs
  • Experience leading global Regulatory Affairs teams within multinational medical device organizations
  • Success driving process improvements and operational excellence programs
  • Experience supporting regulatory inspections, audits, and international authority interactions
  • Strong analytical skills using technology and reporting tools for metrics and tracking

Skills

Regulatory StrategyTeam LeadershipMedical DevicesCompliance ManagementGlobal RegulationsProcess ImprovementStakeholder CollaborationTalent Development

Benefits

  • Competitive Salary
  • Flexible Benefits Package
  • Short-term incentive via Medtronic Incentive Plan (MIP)

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