Senior Regulatory Affairs Specialist
Company: Medtronic
Job Requisition ID: R72459
Employment Type: Full-time
Work Arrangement: Flexible Work Arrangement
Location: Nanakramguda, Hyderabad, India
Posted: 30+ days ago
Role Overview
The Senior Regulatory Affairs Specialist will support global regulatory activities for medical devices, including design and development controls, regulatory submissions, registrations, lifecycle management, regulatory information management, and compliance assessments.
The role involves working with multiple internal functions and international Regulatory Affairs teams to develop regulatory strategies, prepare submission packages, maintain regulatory records, and assess the regulatory impact of product and process changes.
Key Responsibilities
Support Design and Development Control activities by providing regulatory requirements, direction, tactics, and strategies.
Work collaboratively with different organizational departments to support regulatory objectives.
Prepare document packages for:
International regulatory submissions
Internal audits
Regulatory inspections
Establish and support new processes for entering regulatory data into the Regulatory Information Management System (RIMS).
Act as a process Subject Matter Expert (SME) to ensure appropriate coordination and consistent interpretation of required regulatory data attributes.
Stay current with regulatory procedures, regulations, and changes in the regulatory environment.
Provide regulatory data and documentation required for tenders.
Lead the development and maintenance of:
Regulatory files
Regulatory data
Records
Reporting systems
Information-retrieval processes
Prepare, review, and file premarket documentation supporting global registrations for assigned projects.
Collaborate with business units and international Regulatory Affairs teams to support marketing authorizations.
Compile documentation required for:
Regulatory submissions
License renewals
Annual registrations
Recommend changes to labeling, manufacturing, marketing, and clinical protocols to maintain regulatory compliance.
Monitor and improve regulatory tracking and control systems.
Interact with regulatory agencies on defined matters.
Develop regulatory strategies for new or modified products.
Monitor regulatory-environment changes and communicate their potential impact.
Communicate with regulatory agencies and/or notified bodies on administrative and routine matters.
Document, consolidate, and maintain oral and written communications with health authorities.
Prepare internal regulatory documents for device modifications where appropriate.
Author and review regulatory procedures and update them as necessary.
Review change-control documentation and conduct formal regulatory assessments to determine the regulatory impact of internal and external changes.
Required Qualifications
Bachelor's degree in:
Medical field
Mechanical Engineering
Electrical Engineering
Life Sciences
Other healthcare-related discipline
7+ years of Regulatory Affairs experience in the medical device and/or pharmaceutical industry.
Ability to work independently with general supervision on larger and moderately complex projects.
Ability to contribute to completion of project milestones.
Ability to identify and recommend enhancements to systems and processes to solve problems and improve effectiveness.
Ability to quickly establish credibility with stakeholders at different organizational levels.
Strong ability to communicate with internal stakeholders to:
Share information
Communicate status
Identify needs and issues
Gather input
Support decision-making
Preferred Skills
Excellent written and verbal communication.
Strong organizational skills.
Strong interpersonal and stakeholder-management skills.
Flexible and team-oriented approach.
Self-motivated and positive attitude.
Ability to establish credibility quickly with different levels of stakeholders.
Core Competencies
Medical Device Regulatory Affairs
Global Regulatory Submissions
Regulatory Strategy
Product Registration
Regulatory Information Management
Regulatory Data Management
Premarket Documentation
Marketing Authorization
License Renewals
Annual Registrations
Labeling Compliance
Regulatory Impact Assessment
Change Control
Regulatory Procedures
Health Authority Communication
Notified Body Interaction
Audit & Inspection Support
Regulatory Intelligence
Cross-functional Collaboration
Experience Level
This is a senior individual-contributor Regulatory Affairs position requiring 7+ years of experience.
Compared with the Regulatory Affairs Manager role you shared earlier, this position has a lower experience threshold and is more focused on hands-on regulatory execution, regulatory information management, submissions, product lifecycle activities, and regulatory assessments, rather than large-team people leadership.
Location & Work Model
Nanakramguda, Hyderabad, India
Flexible Work Arrangement
Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package, with benefits and resources designed to support employees throughout their careers and personal lives.
The position is eligible for the Medtronic Incentive Plan (MIP), a short-term incentive program.
Recruitment Fraud Alert
Medtronic advises candidates to apply only through official Medtronic recruitment channels. Legitimate recruitment communications come through approved Medtronic platforms and official @medtronic.com email addresses.
Medtronic will not request payment or sensitive financial information during the early stages of recruitment.
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