REGULATORY AFFAIRS SPECIALIST
Company: Medtronic
Location: Hyderabad, India
Department: Regulatory Affairs
Job Type: Full-Time
JOB OVERVIEW
The Regulatory Affairs Specialist supports global regulatory activities for medical devices by developing regulatory strategies, preparing regulatory submissions, maintaining product registrations, ensuring compliance with international regulations, and supporting interactions with global health authorities. The role collaborates with R&D, Quality, Clinical, Manufacturing, and Marketing teams throughout the product lifecycle.
KEY RESPONSIBILITIES
Regulatory Submission Management
Prepare, review, compile, and submit regulatory dossiers for global registrations.
Support:
New product registrations
Product modifications
License renewals
Annual registrations
Maintain submission documentation and regulatory records.
Track submission timelines and approvals.
Regulatory Strategy Development
Develop regulatory strategies for:
New medical devices
Product modifications
Design changes
Provide regulatory guidance during product development.
Support Design Control and Development Control activities.
Assess regulatory pathways and approval requirements.
Product Development Support
Collaborate with R&D and cross-functional teams during product development.
Review:
Pre-clinical protocols
Clinical protocols
Clinical study reports
Technical documentation
Ensure regulatory requirements are incorporated early in development.
Change Control & Impact Assessment
Review change control documentation.
Perform formal regulatory impact assessments.
Determine reporting requirements for design or manufacturing changes.
Support implementation of regulatory compliance actions.
Global Regulatory Compliance
Ensure compliance with:
US FDA regulations
European Union MDR requirements
Indian Medical Device Regulations
International regulatory standards
Monitor evolving regulatory requirements and communicate business impact.
Health Authority Interactions
Maintain communication records with:
FDA
Notified Bodies
International Regulatory Agencies
Support responses to regulatory queries.
Participate in inspections and audits.
Labeling & Promotional Review
Review:
Product labels
IFUs (Instructions for Use)
Promotional materials
Advertising content
Ensure compliance with applicable regulations.
Regulatory Documentation Management
Maintain regulatory files and databases.
Ensure systematic retrieval and archival of regulatory documents.
Support document management systems and regulatory reporting tools.
Audit & Inspection Support
Participate in:
Regulatory inspections
Notified Body audits
Internal quality audits
Support CAPA activities arising from audits.
REQUIRED SKILLS
Regulatory Affairs Skills
Global Regulatory Submissions
Medical Device Regulations
Regulatory Strategy
Product Registration
Technical Documentation
Change Control Assessment
Labeling Compliance
Design Control
Regulatory Knowledge
US FDA Regulations
EU MDR
Medical Device Registration Processes
Regulatory Intelligence
Quality Systems
ISO 13485 Awareness
Risk Management
Technical Skills
Regulatory Documentation Systems
Microsoft Office Suite
Document Control Systems
Submission Tracking Tools
Soft Skills
Regulatory Writing
Attention to Detail
Stakeholder Management
Communication Skills
Negotiation Skills
Problem Solving
Project Management
Cross-Functional Collaboration
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree in:
Life Sciences
Pharmacy
Biomedical Engineering
Medical Devices
Mechanical Engineering
Electrical Engineering
Healthcare-related disciplines
EXPERIENCE REQUIREMENTS
4–7 years of Regulatory Affairs experience.
Experience in:
Medical Device Industry
Pharmaceutical Industry (preferred)
Global Regulatory Submissions
Product Registrations
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