Job Title: Regulatory Affairs Specialist – Flexible/Remote
Location: Nanakramguda, Hyderabad, India (Flexible/Remote Work Arrangement)
Job Type: Full-Time
Experience Required: 4–8 years
Job ID: R50190
Functional Area: Regulatory Affairs / Life Sciences
Company Overview
Medtronic is a global leader in healthcare technology, dedicated to alleviating pain, restoring health, and extending life. With over 95,000 employees worldwide, Medtronic combines innovation, engineering excellence, and a commitment to healthcare access and equity. Our teams work across R&D, manufacturing, regulatory, and clinical operations to deliver life-changing solutions that improve patient outcomes globally.
Role Overview
We are seeking an experienced Regulatory Affairs Specialist to manage regulatory submissions, compliance activities, and license renewals for medical devices. The ideal candidate will be a highly skilled individual contributor with practical knowledge of regulatory procedures, capable of ensuring submissions are accurate, compliant, and delivered on time. This role offers flexibility with remote/flexible work arrangements while driving regulatory excellence in a collaborative, cross-functional environment.
Key Responsibilities
Regulatory Submissions & Compliance
Coordinate and prepare document packages for regulatory submissions, internal audits, and inspections.
Lead or compile materials required for submissions, license renewals, and annual registrations.
Recommend changes to labeling, manufacturing, marketing, and clinical protocols to ensure regulatory compliance.
Monitor and improve submission tracking and control systems.
Strategic & Operational Contribution
Keep abreast of evolving regulatory procedures, guidelines, and industry standards.
Interact with regulatory agencies on defined matters and provide recommendations for expedited clinical trial approvals.
Contribute to cross-functional projects and provide input to enhance regulatory strategy and process improvements.
Mentorship & Guidance
Provide guidance and support to junior colleagues or employees in support roles.
Act as a knowledge resource in regulatory practices and compliance processes.
Required Qualifications & Experience
Education: Bachelor of Technology (B.Tech) – Mandatory.
Experience: 4–7.9 years in regulatory affairs, medical devices, or life sciences.
Strong knowledge of regulatory requirements, submission processes, and compliance standards.
Practical experience in document preparation, license renewals, and regulatory submissions.
Proven ability to work independently on moderately complex projects with general supervision.
Key Skills & Competencies
Effective written and verbal communication skills.
Strong organizational, time management, and problem-solving abilities.
Ability to influence and collaborate across teams and functional areas.
Capacity to adapt to changing environments and provide innovative solutions to regulatory challenges.
Mentorship experience is a plus.
Why Join Medtronic
Competitive salary and flexible benefits package, including Medtronic Incentive Plan (MIP).
Opportunity to work with global healthcare innovators and cutting-edge medical technologies.
Contribute to projects that directly impact patient care and outcomes.
Thrive in an inclusive and diverse environment that values collaboration, innovation, and professional growth.
Equal Opportunity Employer
Medtronic is committed to creating an inclusive and diverse workplace. Employment decisions are made without regard to age, race, gender, sexual orientation, disability, or any other legally protected status.
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