SR. REGULATORY AFFAIRS SPECIALIST
Company: Medtronic
Location: Gurgaon, Haryana, India
Department: Regulatory Affairs
Job Type: Full-Time
JOB OVERVIEW
The Sr. Regulatory Affairs Specialist is responsible for leading regulatory submission activities, managing product registrations and renewals, supporting regulatory compliance initiatives, interacting with regulatory agencies, and driving regulatory strategies to facilitate timely approvals of medical devices and healthcare products globally.
This is a senior individual contributor role involving project ownership, cross-functional collaboration, regulatory strategy development, and mentorship of junior regulatory professionals.
KEY RESPONSIBILITIES
Regulatory Submission Management
Lead preparation and coordination of regulatory submission packages.
Compile and review documentation required for:
Product registrations
License renewals
Annual registrations
Regulatory amendments
Ensure submissions meet regulatory requirements and timelines.
Regulatory Strategy Development
Develop regulatory strategies to support:
New product approvals
Clinical trial applications
Product modifications
Market expansion initiatives
Recommend approaches to achieve the earliest possible regulatory approvals.
Regulatory Compliance
Ensure compliance with:
FDA regulations
EU MDR requirements
International regulatory standards
Local country regulations
Recommend regulatory-compliant changes to:
Product labeling
Manufacturing processes
Marketing materials
Clinical protocols
Regulatory Intelligence
Monitor evolving global regulatory requirements.
Evaluate impact of new regulations on business operations.
Communicate regulatory changes to stakeholders.
Support implementation of regulatory updates.
Health Authority Interaction
Interface with regulatory agencies on assigned matters.
Prepare responses to regulatory queries and deficiencies.
Support inspections and regulatory audits.
Maintain documentation of communications with authorities.
Process & Systems Improvement
Monitor and improve regulatory tracking systems.
Identify process improvement opportunities.
Enhance submission management and compliance workflows.
Develop best practices for regulatory operations.
Project Leadership
Lead regulatory projects independently.
Coordinate activities across:
R&D
Quality Assurance
Clinical Affairs
Manufacturing
Marketing
Ensure project deliverables are completed within timelines.
Mentorship & Guidance
Coach junior Regulatory Affairs Specialists.
Review regulatory documentation prepared by team members.
Provide training and regulatory guidance.
REQUIRED SKILLS
Regulatory Affairs
Global Regulatory Submissions
Product Registrations
License Renewals
Regulatory Strategy Development
Regulatory Intelligence
Regulatory Compliance
Health Authority Interactions
Regulatory Documentation Management
Regulatory Knowledge
US FDA Regulations
EU MDR
Medical Device Regulations
Clinical Trial Applications
Product Lifecycle Management
International Regulatory Requirements
Project Management
Regulatory Project Leadership
Stakeholder Management
Risk Assessment
Timeline Management
Cross-functional Collaboration
Technical Skills
Regulatory Information Management Systems (RIMS)
Document Management Systems
Microsoft Office Suite
Submission Tracking Tools
Soft Skills
Leadership
Coaching & Mentoring
Communication Skills
Negotiation Skills
Problem Solving
Strategic Thinking
Decision Making
Attention to Detail
EDUCATIONAL QUALIFICATIONS
Required
Bachelor's Degree (Baccalaureate)
Preferred
Pharmacy
Life Sciences
Biomedical Engineering
Medical Devices
Biotechnology
Healthcare-related disciplines
Preferred Certifications
RAPS Regulatory Affairs Certification (RAC)
EXPERIENCE REQUIREMENTS
Required
Bachelor's Degree + 4+ years relevant Regulatory Affairs experience
OR
Advanced Degree + 2+ years relevant Regulatory Affairs experience
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