Regulatory Affairs Specialist
Location: Nanakramguda, Hyderabad, India
Work Model: Flexible / Hybrid Work Arrangement
Employment Type: Full-Time
Industry: Medical Devices | Regulatory Affairs | Healthcare Technology
Experience Required: 4–8 Years
Education Requirement: B.Tech (Mandatory)
Job Requisition ID: R50190
Company: Medtronic
Role Overview
Medtronic is seeking an experienced Regulatory Affairs Specialist to support regulatory submission activities, compliance initiatives, and interactions with health authorities. This role plays a critical part in ensuring timely regulatory approvals and ongoing compliance across product lifecycles within a highly regulated medical device environment.
The position is ideal for regulatory professionals with hands-on experience in regulatory submissions, audits, inspections, and labeling compliance, who can operate independently on moderately complex projects.
Key Responsibilities
Regulatory Submissions & Compliance
Coordinate and prepare regulatory submission packages across multiple functions
Compile documentation for new submissions, license renewals, and annual registrations
Support internal audits, external inspections, and regulatory compliance activities
Regulatory Strategy & Lifecycle Management
Recommend updates to labeling, manufacturing processes, marketing materials, and clinical protocols to maintain regulatory compliance
Support strategies to achieve early approvals for clinical trial applications
Monitor regulatory intelligence and stay current with global regulatory procedures and changes
Systems & Process Optimization
Maintain and improve regulatory tracking and control systems
Recommend process enhancements to improve efficiency and compliance
Regulatory Agency Interaction
Participate in defined interactions with regulatory authorities
Support responses to agency queries and regulatory correspondence
Required Qualifications & Experience
Bachelor of Technology (B.Tech) – mandatory
4 to 7.9 years of experience in Regulatory Affairs, preferably within medical devices, healthcare technology, or regulated industries
Practical working knowledge of regulatory submissions, audits, and inspections
Familiarity with regulatory frameworks applicable to medical devices
Professional Competencies
Ability to work independently with minimal supervision on moderately complex projects
Strong organizational and documentation skills
Effective communication with internal stakeholders and cross-functional teams
Capability to mentor or guide junior professionals when required
Analytical mindset with a focus on process improvement and regulatory compliance
Career Level & Impact
Individual contributor role within the Specialist Career Stream
Responsible for end-to-end execution of assigned regulatory projects
Contributes to cross-functional initiatives and project milestones
Applies specialized regulatory knowledge to improve systems and processes
Benefits & Compensation
Competitive salary package
Flexible benefits program
Eligibility for Medtronic Incentive Plan (MIP)
Comprehensive resources to support professional growth and work-life balance
About Medtronic
Medtronic is a global leader in healthcare technology, driven by its mission to alleviate pain, restore health, and extend life. With more than 95,000 employees worldwide, Medtronic delivers innovative medical solutions that improve patient outcomes and expand access to healthcare globally.
Equal Opportunity Statement
Medtronic is an equal opportunity employer and is committed to fostering an inclusive and diverse workplace. Reasonable accommodations are available for individuals with disabilities throughout the recruitment process.
Apply via ThePharmaDaily.com
Explore verified global opportunities in Regulatory Affairs, Medical Devices, Healthcare Compliance, and Regulatory Strategy.
Apply now to advance your regulatory career with Medtronic in Hyderabad.
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