At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be. We want to accelerate and advance our ability to create meaningful innovations – but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives.
Post : Regulatory Affairs Manager
Job Description
This position is based in Nanakramguda, Hyderabad, India and follows a Flexible Work Arrangement model. Limited domestic and international travel may be required to support business objectives, regulatory activities, and stakeholder collaboration. This people leadership role is responsible for leading a Regulatory Affairs team supporting global medical device regulatory activities. The position oversees regulatory submission planning and execution, drives operational excellence, develops regulatory talent, and partners with cross-functional teams to ensure compliance and successful product lifecycle management. The role combines operational leadership, strategic regulatory guidance, and team development responsibilities within a global environment.
Primary Responsibilities
• Lead and develop a Regulatory Affairs team responsible for supporting global regulatory submissions, registrations, renewals, and compliance activities.
• Oversee the preparation, review, and coordination of regulatory documentation packages to support product approvals and lifecycle management activities.
• Develop and execute regulatory strategies that align with business objectives and applicable global regulatory requirements.
• Partner with quality, engineering, clinical, manufacturing, and commercial teams to ensure regulatory compliance throughout the product lifecycle.
• Monitor changes in global regulatory regulations, standards, and guidance documents and assess business impact.
• Drive continuous improvement initiatives to enhance regulatory processes, documentation quality, operational efficiency, and compliance tracking systems.
• Provide leadership during regulatory inspections, audits, agency interactions, and compliance-related activities.
• Manage team performance, resource planning, talent development, succession planning, and employee engagement initiatives.
Candidate Profile
• Bachelor’s degree in Engineering, Biomedical Engineering, Life Sciences, or a related scientific discipline and 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 supporting regulatory submissions, registrations, compliance activities, and regulatory lifecycle management.
• Working knowledge of global medical device regulatory requirements and regulatory agency interactions.
• Effective verbal and written communication skills with the ability to collaborate across 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 driving process improvements, operational excellence programs, and regulatory compliance initiatives.
• Experience supporting regulatory inspections, audits, and interactions with international regulatory authorities.
• Strong analytical skills with experience using technology and reporting tools to support regulatory metrics, tracking, and decision-making.
Additional Information
Experience : Minimum 5 years
Qualification : Bachelor’s degree
Location : Nanakramguda, Hyderabad
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 20th September 2026
Regulatory Affairs Manager : Apply Online
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