PHARMAFull-time
Senior Regulatory Affairs Specialist
By Admin · Regulatory Affairs
HYDERABAD (IN)HYBRIDPOSTED: 10/2/2026
PHARMAFull-time
HIRING ORGANIZATIONMEDTRONICMedical Devices / Healthcare Technology
ROLE OVERVIEW
Senior Regulatory Affairs Specialist responsible for regulatory strategy, submissions, regulatory information management, compliance assessments, and global product registrations. The role supports medical-device and/or pharmaceutical regulatory activities and collaborates with business and international regulatory teams.
ROLE DEFINITION & RESPONSIBILITIES
- •Establish and maintain processes for entering regulatory data into the Regulatory Information Management System
- •Serve as a process subject-matter expert and ensure consistent interpretation of required regulatory data attributes
- •Maintain regulatory files, records, data and reporting systems for systematic information retrieval
- •Prepare, review, file and support premarket documents for global product registrations
- •Collaborate with business units and international regulatory affairs teams to support marketing authorizations
- •Compile materials for regulatory submissions, license renewals and annual registrations
- •Develop regulatory strategies for new or modified products and assess regulatory impact of changes
- •Communicate with regulatory agencies and notified bodies on administrative and routine matters
Reporting Hierarchy: Reports within the Regulatory Affairs function and works cross-functionally with business units, international regulatory affairs personnel, internal departments, regulatory agencies and notified bodies. Exact reporting manager and team size are not specified in the source posting.
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor’s degree in medical, mechanical, electrical, life science or another healthcare-related discipline
- 7+ years of Regulatory Affairs experience in the medical-device and/or pharmaceutical industry
- Experience supporting regulatory submissions and product registrations
- Ability to work independently with general supervision on moderately complex projects
- Ability to contribute to project milestones and improve systems and processes
PREFERRED QUALIFICATIONS
- •Strong communication and interpersonal skills
- •Strong written, organizational and communication skills
- •Flexible and team-oriented approach
- •Self-motivated and positive attitude
- •Ability to establish credibility with internal stakeholders and customers
REQUIRED VERIFIED SKILLS
Regulatory Affairs
regulatory submissions
global registrations
marketing authorization
Regulatory Information Management System
regulatory data management
regulatory strategy
change control
regulatory impact assessment
medical devices
pharmaceutical regulations
license renewals
annual registrations
labeling compliance
health authority communication
notified bodies
audits
inspections
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Competitive salary; flexible benefits package; short-term incentive through the Medtronic Incentive Plan (MIP); employee resources supporting career and life stages
The source posting does not disclose a salary range. Compensation should therefore be treated as undisclosed; the role's 7+ year experience requirement indicates a senior-level compensation tier, but no numeric benchmark is asserted here.
ORGANIZATION CONTEXT & CULTURE
Medtronic is a global healthcare technology company with a mission to alleviate pain, restore health and extend life. The company develops innovative medical technologies and serves patients across more than 150 countries.
TEAM SIZE: 95,000+ employees
INDUSTRY: Medical Devices / Healthcare Technology
Culture: Mission-driven and collaborative environment focused on patient impact, regulatory compliance, innovation and cross-functional teamwork.
EXPECTED CAREER ROADMAP
This role can progress toward Regulatory Affairs leadership, global regulatory strategy, regulatory program management, or senior specialist/managerial positions supporting increasingly complex products and international markets.
APPLICATION ADVISORY
Highlight 7+ years of medical-device or pharmaceutical Regulatory Affairs experience; emphasize global submissions, registrations, regulatory strategy and change-control assessment; demonstrate experience with regulatory information systems and health-authority interactions; quantify relevant submission, registration or process-improvement achievements where possible.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
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